Getting to answers with clinical trials: Being bold...Getting to answers with clinical trials: Being...
Transcript of Getting to answers with clinical trials: Being bold...Getting to answers with clinical trials: Being...
Getting to answers with clinical trials: Being bold
Prof. Thomas ZellerDepartment AngiologyUniversity Heart-Center Freiburg - Bad KrozingenBad Krozingen , Germany
Faculty Disclosure
For the 12 months preceding this presentation, I disclose the following types of financial relationships:
• Honoraria received from: Abbott Vascular, Angioslide, Bard Peripheral Vascular, Veryan, Biotronik, Boston Scientific Corp., Cook Medical, Cordis Corp., Covidien, Gore & Associates, Medtronic, Spectranetics, Straub Medical, TriReme, VIVA Physicians
• Consulted for: Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corp., Cook Medical, Gore & Associates, Medtronic, Spectranetics, ReCor
• Research, clinical trial, or drug study funds received from:480 biomedical, Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, Cordis Corp., Covidien, Gore & Associates, Abbott Vascular -DEV Technologies, Inc., Medtronic, Spectranetics, Terumo, TriReme, Volcano
• Thomas Zeller, MD
Landscape of PAD treatment
• Treatments for PAD are growing and changing – PTA and Bare Metal Stents are used most often – Leave nothing behind can include multiple strategies
• Atherectomy• PTA• DCB
• Each RCT is unique• RCT are not equal to the Registry
– Registries are often not as rigorous as RCTs• Core lab• DSMB/CEC• Patient population
• Data are needed to determine the best path forward
BMS, DES, DCB, Atherectomy
Drug Eluting Stents - Peripheral
SFA BTK
Zilver PTXCook Medical
Eluvia™ DESBoston Scientific
Promus Element PlusBTK
Boston Scientific
Xience Prime BTKAbbott Vascular
Product Image
CE Mark/US Approval
CE US CE US CE US CE US
No
Not indicated for BTK in
US
No
Stent Platform Zilver Flex Innova Promus Premier
Material Nitinol Nitinol Platinum Chromium Alloy Cobalt Chromium
Polymer NoneBiostable Fluorinated
Polymer MatrixBiostable Fluorinated
Polymer MatrixBiostable Fluorinated
Polymer Matrix
Drug Paclitaxel Paclitaxel Everolimus Everolimus
Deployment Self-expandable Self-expandable Balloon Expandable Balloon Expandable
SizesDiameter Length Diameter Length Diameter Length Diameter Length
6-8mm 40-120mm 6-7mm 40-150mm 2.25-4mm 12-38mm 2.5-4mm 28-38mm
www.abbottvascular.com/int/products/peripheral-intervention/xience-prime-btk.html#ordering-information.
www.medicalexpo.com/prod/abbott-vascular/peripheral-stents-drug-eluting-90137-572891.html
Cook Medical (2014). Zilver PTX Drug-Eluting Peripheral Stent Instructions for Use
http://zilverptx.cookmedical.com/us/index.html#
Drug-Coated Balloons - Peripheral
IN.PACT Admiral Medtronic
LutonixTM
BardStellarex™
SpectraneticsRanger™
Boston Scientific
Product Image
Paclitaxel Dose 3.5 µg/mm2 2 µg/mm2 2 μg/mm2 2 µg/mm2
Coating TechnologyFreePac™ hydrophilic coating
(excipient: urea)Proprietary hydrophilicnonpolymeric carrier
EnduraCoat™ coating(excipient: Poly-ethylene
Glycol)
TransPax coating(excipient: Citrate ester)
Guidewire Compatibility
0.035 OTW 0.035 OTW 0.035 OTW 0.14/0.18
MatrixSFA: 4-7 mm; 40-120 mm
BTK: Recalled
SFA: 4-6 mm; 40-100 mm
SFA: 4-6 mm;40-120 mm
SFA: 4-8 mm;30-100 mm
BTK: 2-4 mm; up to 150 mm
CE Mark
FDA Approval
Atherectomy Devices
Jetstream™
Atherectomy System
(Boston Scientific)
Diamondback 360™,
Stealth 360™
Atherectomy System
(Cardiovascular
Systems, Inc)
SilverHawk™,
TurboHawk™
Plaque Excision System
(Covidien)
Turbo-Elite™
Laser Atherectomy
Catheter
(Spectranetics)
Product Image
Front-Cutting ()
Differential Cutting NA
Active Aspiration
Concentric Lumens
Lesion Morphology:
Calcium 2,3 4 (large vessel only)1 () 1
Soft/Fibrotic Plaque 2 5 1
Thrombus 1 contraindicated1 1
In-stent restenosis 6 (), not approved 7
1. Instructions for Use/product website. 2. Zeller T, et al. J Endovasc Ther. 2009;16(6):653-662. 3. Maehara A, et al. EuroIntervention. 2015 19;11(1):96-103. 4. Shammas N, et al. J
Endovascular Ther, 2012; 19:480-488. 5. McKinsey JF, et al. JACC Cardiovasc Interv. 2014 ;7(8):923-33. 6. Shammas NW, et al. J Endovasc Ther. 2016 ;23(2):339-46. 7. Dippel
EJ,et al. JACC Cardiovasc Interv. 2015 ;8(1 Pt A):92-101.
Outcomes for BMS, DES, DCB studies
Shishebor M, Jaff M. Circulation 2016.
Device Rutherford Class, % Lesion Length Patency, %II III IV mm Year 1 Year 2 Year 3 Year 4 Year 5
Wire interwoven Nitinolstents
37.5 57.2 5.3 78.1 86.3 NA NA NA NA
Drug-elutingstents
90.3 8.9 66.4 83.1 76.3 71.5 67.4 66.4
Covered stent59,60 18 68 3 189.8
7378
69.4 24.2 NA NA
Drug-coated balloons
Lutonix 29.4 62.7 7.9 62.8 65.2 58.6 NA NA NA
In.PACT 37.3 57.3 5.4 89.4 83.2 78.9 NA NA NA
Outcomes for Atherectomy studies
Device Name*Mechanism of
ActionStudy
No. of Patients/Lesions
Procedural Success Rate
Procedural Complication Rate
Diamondback 360 Orbital
CALCIUM 360°79 50/6493.1% in OA with PTA vs 82.4% in PTA alone
Bailout stenting 6.9% vs 14.3% in
PTA alone
OASIS81 124/201 90.1% 2.5%
COMPLIANCE 36082 50/65
Residual stenosis ≤30% w/o stenting: 86.8% in
OA vs 18.5% in PTA
Stenting in 5.3% in the OA vs 77.8%
CONFIRM series83 3,135/4,766
OA decreased preprocedural stenosis from an avg of 88% to
35%
Stenting in <5.7%
Excimer Laser Photoablative
LACI73 145/155
Procedural success (<50% residual
stenosis) in 85% of the limbs
Procedural complication in 12%
of the limbs
EXCITE ISR74 25093.5% in ELA + PTA vs
82.7% in PTA alone
Bailout stenting of 4.1% in ELA+PTA vs 11.1% in PTA alone
JetstreamRotational / Aspirational
TRUE78 18Increase in mean
luminal volume of 64.3 mm3
0%
Silverhawk/Turbohawk
Excisional / Directional
DEFINITIVE LE75 799/1022 89%Bailout stenting
3.2%
Shishebor M, Jaff M. Circulation 2016.
Peripheral InterventionHistorical Patient Populations
* Transatlantic Inter-Society Consensus (TASC ) II Lesion Classification (Type A, B, C, D ) for Peripheral Arterial Disease
Simple Complex
A* B C D
POBA
DCB
Stents (Bare, Covered, DES)
Surgery
Longer, more calcium
• DEFINITIVE AR: directional atherectomy + DCB vs DCB alone
• Adjunctive atherectomy may improve procedural and clinical outcomes following DCB treatment of the SFA and/or popliteal artery, particularly for longer or severely calcified lesions
Adjunctive treatment? DCB+Atherectomy: Clinical Evidence
Zeller, VIVA 2014.
*Technical success: Defined as ≤ 30% residual stenosis following the protocol-defined treatment at the target lesion as determined
by the Angiographic Core Laboratory. DCB, drug-coated balloon; DUS, duplex ultrasound; SFA, superficial femoral artery
DCB Ath + DCB
Technical Success* 64.2% 89.6%
Bail-out Stent 3.7% 0%
Flow-limiting Dissection 19% 2%
Procedural Results
86%
63%
90%97%
70%
93%
0%
20%
40%
60%
80%
100%
Lesions >10 cm Severely Calcified All patients
DCB DCB + Ather
n=23 n=8 n=27 n=54 n=48n=31
Duplex Ultrasound Patency at 12-months
Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: results from the IN.PACT DEEP randomized trial• Multicenter RCT• 358 CLI patients• Randomized DEB vs PTA 2:1• Primary endpoints
– Clinically driven lesion TLR– Late lumen loss– 6 months composite mortality, major amp, CD-TLR
Zeller T , J Am Coll Cardiol 2014
InPact Deep RCT
DEB PTA
Clinically Driven TLR 9.2% 13.1%
Late Lumen Loss 0.61 ± 0.78 0.62 ± 0.78
Major Amputation 8.8% 3.6% (P=0.08)
Primary Safety(mortality, major amputation, CD TLR)
17.7% 15.8%
Below the kneeDCB vs PTA
Systematic Review of infrapopliteal DES: A meta-analysis of randomized controlled trials
• 3 RCTs with 501 patients– Achilles: DES vs PTA in CLI & IC, n=200
– Destiny: DES vs BMS in CLI, n=140
– Yukon-BTX: DES vs BMS in CLI & IC, n=161
• Relatively short and focal infrapopliteal lesions
Katsanos K et al, Cardiovasc Intervent Radiol 2013
Below the kneeDES vs PTA/BMS
InfraPop: Meta-Analysis of RCT
Results at 1 year DES PTA/BMS P=
Primary Patency 80.0% 58.8% <0.0001
Rutherford class improvement 79.0% 69.6% 0.045
Wound healing 76.8% 59.7% 0.04
TLR 9.9% 22.0% 0.001
Event-free survival 72.2% 57.3% <0.0001
Survival 85.5% 86.6% 0.75
Amputation 6.4% 10.8% 0.11
PADI CLI: PTA±BMS vs DES for infrapopliteal lesions
• Multi-center randomized two-arm study• 136 patients with 144 limbs
– CLI, Rutherford 4-6– De novo stenoses or occlusions below knee
joint– Vessel diameter 2-6 mm, length ≤ 90 mm
• PTA±BMS or paclitaxel-DES (Taxus Liberté)• Heparin, Aspirin, Clopidogrel
Overhagen et al. Circ Cardiovasc Interv 2016
Below the knee DES vs PTA/BMS
Putting it all together…
Katsanos K: J Vasc Surg 2014;59;1123-1133
Baseline risk adjusted random effects mixed treatment comparison
Clinical results of Drug-Eluting Technologies
Network meta-analysis of RCTs of endovascular treatmentPOBA vs. DCB vs. DES vs. BMS vs. Covered stents
Results:
TLR lowest with paclitaxel-coated balloon and paclitaxel-eluting stent
Vascular restenosis lowest with paclitaxel-eluting stent and paclitaxel-coated balloon
Gaps in the data?
• DCB in Complex Lesions
• DCB vs DES
• Atherectomy + DCB
• DCB vs DCB
• DES vs DES
• Primary patency or TLR? Relavance?
• BTK? We need more data
Clinical Study DataImportant Characteristics and Outcomes
Clinical CharacteristicsAngiographic
CharacteristicsOutcomes
Demographics (age, sex, socioeconomic class)
Lesion location, lengthPatency (primary, assisted primary,
secondary)
Diabetes mellitus CalcificationClinically driven target lesion
revascularization
Chronic kidney disease Number of runoff 6-minue walk test
Rutherford class Stenosis versus occlusion Quality-of-life metrics
Ankle brachial index De novo versus restenosis Amputation free survival
Toe brachial index Major adverse limb events
Comorbid coronary, cerebrovascular conditions
Time to wound healing
Wound location, size, and depth Time to ambulation
Soft tissue/bone infection Hospital length of stay
Readmission
Total medical expense
Shishebor M, Jaff M. Circulation 2016.
Clinical StudiesMeaningful Endpoints
Late Lumen Loss
Important to:
•Physicians
•Regulatory agencies
Primary Patency
Important to:
•Physicians
•Regulatory agencies
Freedom from TLR
Important to:
•Physicians
•Patients
•Payers
•Regulatory agencies???
Patient Outcomes
Important to:
•Physicians
•Patients
•Payers
•Regulatory agencies
Randomized Controlled Trials Real world studies
Being Bold, BSC approach to finding the answers
Prospective, multicenter, single-arm, open label
n= 57 (2yr follow-up complete)
Prospective, multicenter, RCT 2:1 (Eluvia : Zilver PTX)
n = 485 (Enrolling)
Prospective, multicenter, RCT 2:1 (Eluvia : BMS)n = 750 (Enrolling)
Prospective, multicenter, single-arm, open labeln = 500 (Enrolling)
Prospective, multicenter, randomizedn = 105
Prospective, multicenter, RCT 3:1 (Ranger : POBA)• n = 376
Prospective, multicenter, single-arm• n = 123
IMPERIAL(DES)
MAJESTIC(DES)
EMINENT(DES/BMS)
REGAL(DES)
Ranger II(DCB)
Boston Scientific Drug ElutionClinical Program
Ranger FIM(DCB)
Ranger China(DCB)
Boston Scientific Global Pivotal StudyIMPERIAL Trial
Clinical Study Overview: IMPERIAL
Title A randomIzed trial coMParing the ELUVIA dRug-elutIng stent versus Zilver PTX stent for treatment of superficiAL femoral and/or proximal popliteal arteries
Primary Investigators Global: William A. Gray, MD
European: Prof. Dr. med Stefan Müller-Hülsbeck
Objective To evaluate the safety and effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length.
Study Design The trial consists of the following:
• A prospective, multicenter, 2:1 randomized (ELUVIA vs Zilver PTX), controlled, single-blind, non-inferiority trial (RCT)
• A concurrent, non-blinded, single-arm, pharmacokinetic(PK) sub-study
• A concurrent, non-blinded, non-randomized, single arm Long Lesion sub-study (lesions 140mm-190mm in length treated with ELUVIA)
Subjects • 465 subjects treated with ELUVIA (N=310) or Zilver PTX (N=155)
• 12-20 subjects treated with ELUVIA in the PK sub-study
• 50 subjects treated with ELUVIA in the Long Lesion sub-study
Investigational Centers Up to 75 centers in US, Canada, New Zealand, Belgium, Germany, Austria, and Japan
Boston Scientific Global Pivotal StudyIMPERIAL Trial
Clinical Study Overview: IMPERIAL
Primary Efficacy Endpoint
Primary vessel patency as assessed by duplex ultrasound (DUS) at 12 months post-procedure and adjudicated by an independent core laboratory.
Primary Safety Endpoint
Major Adverse Event (MAE) rate defined as• All cause death through 1 month• Target limb major amputation through 12 months• Target lesion revascularization (TLR) through 12 months
Study Stents Zilver PTX Eluvia
Medicinal Substance Paclitaxel Paclitaxel
Coating Design No carrier PROMUS Polymer
Drug/Total Dose3µg/mm2
8 x 120mm = 1112 µg0.167µg/mm2
7 x 150mm = 517 µg
Size Matrix6-8mm
40-120mm 6 & 7mm
40-150 mm
SEM Image 100x
Boston Scientific Global Pivotal StudyRANGER II SFA
Clinical Study Overview: RANGER II SFA
Title A 3:1 Randomized Trial Comparing the Boston Scientific RANGER Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA)
Primary Investigators Global: Prof. Thomas Zeller, MD - Germany
National: Ravish Sachar, MD, FACC – United States
Objective To evaluate the safety and effectiveness of the RANGER™ Paclitaxel Coated Balloon for treating lesions located in the SFA and PPA
Study Design The trial consists of the following:• Prospective, multicenter, single-blind, superiority, RCT 3:1 (RANGER DCB : Standard PTA)• A concurrent, non-blinded, single-arm, pharmacokinetic(PK) sub-study
Subjects 396 patients• At least 376 patients into the randomized arm• 12 to 20 subjects in the non-randomized PK Sub-study
Investigational Centers
Up to 70 study centers in Canada, Europe (Austria, Belgium, Germany, Poland), Japan, New Zealand, and U.S.
Primary EfficacyEndpoint
Primary Patency of lesion• Determined by DUS and absence of clinically driven TLR
Primary Safety Endpoint
Occurrence of MAEs • All-cause death at 1 Month• TLR at 12 Months• Target limb major amputation at 12 Months
RANGER II SFAStudy Flow
Do Not Enroll
NO
NO
Guidewire crosses target lesionSuccessful pre-dilation
Obtain randomization code (3:1)
Post-dilation per discretionPost-procedure & Pre-discharge
Assessments
End of Study
Signed ICF & Baseline Testing
Eligibility criteria met
3:1282RANGER
investigational balloon 94Standard PTA
commercial balloon
NO
Follow-up Evaluations
Office : 1, 6, 12, 24, 36 Month FU
Office / Phone: 48, 60 Month FU
Prospective, multicenter, RCT 1:1:1
• N = 222
Prospective, multicenter, RCT 1:1N = 200
Prospective, RCT 1:1 (Ranger : InPact)N = 150 , study extended to 414 patients
Prospective, multicenter, registry N = 180
Feasibility, observational, angio F/UN = 30
Prospective, RCT 1:1 (Ranger vs PTA)N = 70
Prospective, multicenter, RCT 2:1 (JS+Ranger : POBA+Ranger)N = 250
Hemodialysis AVF Rescue
SPORTS
SFA RCT
SFA Registry
BTK Clinical
Investigator Sponsored Research Drug Elution (DES and DCB)
BTKAngiographic
JET-PCB(IDE)
These investigator-sponsored studies are supported by grant funding from Boston Scientific. Boston Scientific is not responsible for the collection, analysis or
reporting of these studies which remain the sole responsibility of the investigators. Information for the use in countries with applicable product registrations.
Clinical Study Overview: COMPARE I Pilot Study
TitleProspective, Randomized, Multi-center Study for the Treatment of Subjects with Symptomatic Femoropopliteal Artery Disease with the Ranger™ Paclitaxel Coated PTA Balloon Catheter (study arm) vs. the IN.PACT™ Drug Eluting Balloon (control arm)
Primary Investigator / Sponsor
Dierk Scheinert, MD – Germany
VascuScience GmbH – Leipzig, Germany
ObjectiveTo compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in the SFA and/of PPA
Study Design Prospective, multicenter, RCT 1:1 (Ranger DCB : InPact DCB)
Subjects 150 patients
Investigational Centers 15 centers in Germany
Primary Efficacy EndpointPatency rate after 1yr defined as absence of clinically driven TLR (due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure baseline) or restenosis with PVR > 2.4 evaluated by DUS
Primary Safety EndpointComposite of freedom from device and procedure-related death through 12m post procedure as well as freedom from both target limb major amputation and clinically-driven TVR
COMPARE I PilotInvestigator Sponsored Research
Clinical Study Overview: COMPARE I Pilot Study Extension
TitleProspective, Randomized, Multi-center Study for the Treatment of Subjects with Symptomatic Femoropopliteal Artery Disease with the Ranger™ Paclitaxel Coated PTA Balloon Catheter (study arm) vs. the IN.PACT™ Drug Eluting Balloon (control arm)
Primary Investigator / Sponsor
Dierk Scheinert, MD – Germany
VascuScience GmbH – Leipzig, Germany
ObjectiveTo compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in the SFA and/of PPA
Study Design Prospective, multicenter, RCT 1:1 (Ranger DCB : InPact DCB)
Subjects 150 patients 414 patients
Investigational Centers 15 centers in Germany
Primary Efficacy EndpointPatency rate after 1yr defined as absence of clinically driven TLR (due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure baseline) or restenosis with PVR > 2.4 evaluated by DUS
Primary Safety EndpointComposite of freedom from device and procedure-related death through 12m post procedure as well as freedom from both target limb major amputation and clinically-driven TVR
COMPARE I ExtenstionInvestigator Sponsored Research
SPORTS trialInvestigator Sponsored Research
Clinical Study Overview: JET-PCB Trial (Investigator sponsored IDE)
Title Sequent Please Drug coated balloons versus primary stent application in long SFA lesions
Primary Investigator / Sponsor
Prof. Dr. med. Gunnar Tepe - Germany
InnoRa GmbH Berlin
ObjectiveTo show superiority in terms of diameter stenosis 12 months after intervention of long lesionswith PES compared to NS (hypothesis 1a) and non-inferiority in terms of diameter stenosis 12 months after intervention of long lesions with PCB compared to NS (hypothesis 2a).
Study Design
A prospective, multicenter, open, RCT 1:1:1• PTA with PES• PTA with PCB• PTA with NSHypothesis 1a =
Study Devices PES – Eluvia™; PCB - SeQuent®; NS – SMART, Zilver, Innova, Absolut, LIfeStent, Everflex
Subjects 222 subjects (74 per treatment arm)
Investigational Centers 9 – 11 Centers in Germany and Austria
Primary Endpoint Percent diameter stenosis (DS) at 12 M as assessed by quantitative angiography
PES=paclitaxel-eluting stent; PCB=paclitaxel-coated balloon
PTA=Percutaneous transcatheter angioplasty; NS=Nitinol Stent
JET-PCB studyInvestigator Sponsored Research
Clinical Study Overview: JET-PCB Trial (Investigator sponsored IDE)
TitleJETStream Atherectomy with Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty followed by Paclitaxel-Coated Balloon in Treating Complex Denovo FemoropoplitealArterial Disease
Primary Investigator / Sponsor
Nicolas W. Shammas, MD
Midwest Cardiovascular Research Foundation
Objective
To evaluate the use of Jetstream Atherectomy (JS) followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by DCB alone in the treatment of complex lesions in femoropopliteal arteries (Rutherford Cat 2-4)Complex lesions are defined:• Long lesions (≥ 10 cm)• Moderately or highly calcified lesions• Chronic total occlusions (irrespective of length)
Study Design A prospective, multicenter, 2:1 randomized (JS ath+Ranger DCB : POBA+DCB),
Subjects 250 subjects (~167 DCB+JS vs 83 POBA+DCB)
Investigational Centers Up to 25 study sites in US
Primary Efficacy Endpoint
TLR at 1 year, TLR defined as:• Retreatment of the index lesion (extended 1 cm prox and dist to the lesion) at 1 year.• For the primary endpoint, intra-procedural bail out stenting of the index lesion is considered
meeting a TLR endpoint
Primary Safety Endpoint
MAE at 30 days• Unplanned amputation• Total mortality• TLR (includes bailout stenting)
Below the Knee Studies - DCB
Ranger BTKA safety and efficacy study to evaluate Ranger drug-eluting
balloon for below the knee angioplasty in patients with critical limb ischemia
CRURAL DEBRandomized trial comparing drug coated balloon vs plain
balloon angioplasty in critical limb ischemia and treatment of long lesions in crural arteries
PI Marc Sapoval PI Torbjorn Fransson
Design Prospective, single centre, non-controlled, open-label
Design Prospective, single centre, randomized
Centres France Centres Sweden
Population 30 patients Population 70 patients
Primary Efficacy Endpoint
Primary patency (no stenosis >50%) and Late Lumen Loss (LLL) of the Target Lesion measured by Quantitative Vascular Angiography (QVA) at 6 months adjudicated by independent core lab
Primary EfficacyEndpoint
12 month primary patency
Primary Safety Endpoint
Composite of all death and major amputation at 6 and 12 months
SecondaryEndpoints
TLR, Event Free Survival, MRA analysis
Ranger DCB – BTKInvestigator Sponsored Research
Conclusions
• The amount of clinical data surrounding PAD therapies is rapidly increasing
• Boston Scientific has a broad portfolio of clinical studies with the goal of advancing the evidence for various PAD treatment technologies– Large Head-to-head randomized trials
– Complex lesions being studied
– Adjunctive therapies being studied
– Inclusion of more endpoints including cost effectiveness
• The future is exciting in the landscape for endovascular treatment for PAD, specifically in regards to Drug Elution technologies
• IMPORTANT INFORMATION: These materials are intended to describe common clinical considerations and procedural steps for the on-label use of referenced technologies as well as current standards of care for certain conditions. Of course, patients and their medical circumstances vary, so the clinical considerations and procedural steps described may not be appropriate for every patient or case. As always, decisions surrounding patient care depend on the physician’s professional judgment in light of all available information for the case at hand.
• BSC does not promote or encourage the use of its devices outside their approved labeling.
• The presenter’s experience with BSC products may not be interpreted or relied upon to support clinical claims about BSC devices or product comparison claims regarding BSC and competitive devices. The experiences of other users may vary.
• Results from case studies are not predictive of results in other cases. Results in other cases may vary.
Getting to answers with clinical trials: Being bold
Prof. Thomas ZellerDepartment AngiologyUniversity Heart-Center Freiburg - Bad KrozingenBad Krozingen , Germany