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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 : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Dierk Scheinert, University of Leipzig

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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: Ranger Drug Eluting Balloon Device: In Pact Drug Eluting Balloon Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 2015
Actual Primary Completion Date : October 2018
Estimated Study Completion Date : October 2023

Arm Intervention/treatment
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
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

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.
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Target Lesion Revascularization (TLR) rate [ Time Frame: 6,12,24 months ]
    Target Lesion Revascularization rate at 6, 12, 24, 36, 48 and 60 months

  2. Walking capacity [ Time Frame: 6,12,24 months ]
    Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6, 12 and 24 months versus baseline.

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701543


Locations
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Germany
University Clinic Leipzig
Leipzig, Saxony, Germany, 04103
Sponsors and Collaborators
University of Leipzig
Investigators
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Principal Investigator: Dierk Scheinert, Prof.Dr. University Leipzig
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Dierk Scheinert, Prof. Dr., University of Leipzig
ClinicalTrials.gov Identifier: NCT02701543    
Other Study ID Numbers: CIP_14/001
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases