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Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02701543
Recruitment Status : Active, not recruiting
First Posted : March 8, 2016
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Dierk Scheinert, University of Leipzig

Tracking Information
First Submitted Date  ICMJE January 19, 2016
First Posted Date  ICMJE March 8, 2016
Last Update Posted Date November 5, 2020
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
  • Patency rate [ Time Frame: 1 year ]
    Efficacy: patency rate after one year defined as absence of clinically driven Target Lesion Revascularization (due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure ) or restenosis with Peak Velocity Ratio > 2.4 evaluated by Duplex Ultrasound
  • Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization [ Time Frame: 1 year ]
    Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
  • Target Lesion Revascularization (TLR) rate [ Time Frame: 6,12,24 months ]
    Target Lesion Revascularization rate at 6, 12, 24, 36, 48 and 60 months
  • Walking capacity [ Time Frame: 6,12,24 months ]
    Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6, 12 and 24 months versus baseline.
  • binary restenosis [ Time Frame: 6,12,24 months ]
    Duplex-defined binary restenosis (Peak systolic velocity ratio >2.4) of the target lesion post-procedure and at 6, 12 and 24 months or at any time of re-intervention
  • improvement shift in Rutherford classification [ Time Frame: 6,12,24 months ]
    Sustained clinical improvement: an improvement shift in the Rutherford classification of one class in amputation and Target Vessel Revascularization free surviving patients at 12 months
  • secondary Safety [ Time Frame: 60 months ]
    Composite of freedom from device and procedure-related death through 60 months post procedure as well as freedom from both target limb major amputation and clinically-driven target vessel revascularization
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
  • Target Lesion Revascularization (TLR) rate [ Time Frame: 6,12,24 months ]
    Target Lesion Revascularization rate at 6, 12 and 24 months
  • Walking capacity [ Time Frame: 6,12,24 months ]
    Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6, 12 and 24 months versus baseline.
  • binary restenosis [ Time Frame: 6,12,24 months ]
    Duplex-defined binary restenosis (Peak systolic velocity ratio >2.4) of the target lesion post-procedure and at 6, 12 and 24 months or at any time of re-intervention
  • improvement shift in Rutherford classification [ Time Frame: 6,12,24 months ]
    Sustained clinical improvement: an improvement shift in the Rutherford classification of one class in amputation and Target Vessel Revascularization free surviving patients at 12 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease
Official Title  ICMJE Prospective, Randomized, Multi-Center Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease With the Ranger Paclitaxel Coated PTA Balloon Catheter (Study Arm) Versus the IN.PACT Drug Eluting Balloon (Control Arm)
Brief Summary To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal Artery in Peripheral Artery Disease (PAD) patients with Rutherford class 2-4.
Detailed Description

This study is a prospective, multi-center 1:1 randomized trial. Patients will be stratified according to lesion length (≤ 10 cm/ > 10 cm and < 20 cm / > 20 cm and ≤ 30 cm). Each strata will include approximately 138 patients.

The trial is to investigate the safety and efficacy of the Ranger™ Drug Coated Balloon in comparison to the IN.PACT™ Drug Coated Balloon in patients with symptomatic femoropopliteal artery disease.

All enrolled subjects will be followed through to 24 months to assess the incidence of restenosis by ultrasound and major adverse events (MAE). Follow-up visits occur at 1, 6, 12 and 24-month intervals per local standard of care. Telephone follow-up visits will occur at 36, 48 and 60 month.

Up to 414 patients will be enrolled at approximately 10-18 sites in Germany for comparison between the following two groups:

Treatment with the Ranger™ Paclitaxel Coated Balloon Catheter (Boston Scientific Corporation, Natick, MA, USA) vs. the IN.PACT™ Drug Eluting Balloon (Medtronic Inc., Minneapolis, MI, USA).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Artery Disease
Intervention  ICMJE
  • Device: Ranger Drug Eluting Balloon
    Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
  • Device: In Pact Drug Eluting Balloon
    Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
Study Arms  ICMJE
  • Active Comparator: Ranger Drug Eluting Balloon
    Intervention with Over the Wire (OTW) Percutaneous transluminal angioplasty (PTA )balloon catheter with a semi-compliant balloon coated with a formulation of 2μg/mm2 paclitaxel and acetyl tri-n-butyl citrate (ATBC) as carrier substance
    Intervention: Device: Ranger Drug Eluting Balloon
  • Active Comparator: In Pact Drug Eluting Balloon
    Intervention with Over the Wire (OTW) peripheral balloon catheter. The balloon surface is coated with a formulation of 3μg/mm2 paclitaxel and urea as carrier substance.
    Intervention: Device: In Pact Drug Eluting Balloon
Publications * Steiner S, Schmidt A, Zeller T, Tepe G, Thieme M, Maiwald L, Schröder H, Euringer W, Ulrich M, Brechtel K, Brucks S, Blessing E, Schuster J, Langhoff R, Schellong S, Weiss N, Scheinert D. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J. 2020 Jul 14;41(27):2541-2552. doi: 10.1093/eurheartj/ehaa049.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 10, 2017)
414
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2016)
150
Estimated Study Completion Date  ICMJE October 2023
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject age ≥ 18
  2. Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing Rutherford category 2-4.
  3. Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
  4. Target lesion length is ≤ 30cm
  5. Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle.
  6. Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 30 cm.
  7. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.
  8. Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery.
  9. A guidewire has successfully traversed the target treatment segment.

Exclusion Criteria:

  1. Failure to successfully cross the target lesion
  2. Angiographic evidence of severe calcification
  3. Presence of fresh thrombus in the lesion.
  4. Presence of aneurysm in the target vessel/s
  5. Presence of a stent in the target lesion
  6. Prior vascular surgery of the target lesion.
  7. Stroke or heart attack within 3 months prior to enrollment
  8. Any surgical procedure or intervention performed within 30 days prior to or post index procedure
  9. Superficial femoropopliteal Artery or Proximal popliteal artery disease in the opposite leg that requires treatment at the index procedure
  10. Target lesion requires treatment with alternative therapies such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices
  11. Enrolled in another investigational drug, device or biologic study
  12. Life expectancy of less than one year
  13. Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
  14. Rutherford classification of 0, 1, 5 or 6.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02701543
Other Study ID Numbers  ICMJE CIP_14/001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dierk Scheinert, University of Leipzig
Study Sponsor  ICMJE University of Leipzig
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dierk Scheinert, Prof.Dr. University Leipzig
PRS Account University of Leipzig
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP