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

Peripheral Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701543
• Other study ID #: CIP_14/001
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 414
• Est. completion date: December 2023
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	University Clinic Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency rate	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	1 year
Primary	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	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	1 year
Secondary	Target Lesion Revascularization (TLR) rate	Target Lesion Revascularization rate at 6, 12, 24, 36, 48 and 60 months	6,12,24 months
Secondary	Walking capacity	Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6, 12 and 24 months versus baseline.	6,12,24 months
Secondary	binary restenosis	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	6,12,24 months
Secondary	improvement shift in Rutherford classification	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	6,12,24 months
Secondary	secondary Safety	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	60 months