Peripheral Artery Disease
Conditions
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).
Interventions
DEVICERanger 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
DEVICEIn 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
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patency rate | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| binary restenosis | 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 |
| Target Lesion Revascularization (TLR) rate | 6,12,24 months | Target Lesion Revascularization rate at 6, 12, 24, 36, 48 and 60 months |
| secondary Safety | 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 |
| improvement shift in Rutherford classification | 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 |
| Walking capacity | 6,12,24 months | Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6, 12 and 24 months versus baseline. |
Countries
Germany
Outcome results
None listed