Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease

Head-to-Head Comparison of SIROlimus Versus Paclitaxel Drug-Eluting BallooN Angioplasty in the Femoropopliteal Artery

This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial.

The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with PTX drug-coated balloon (control device) in patients with femoropopliteal artery disease.

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. The long-term success of bare balloon PTA in the fem-oropopliteal segment is hampered by the occurrence of restenosis, which can be reduced by local antiproliferative drug delivery via the PTA balloon catheter.

The rationale of this study is based on the hypothesis that the usage of the Sirolimus-coated Magic Touch Sirolimus DCB is at least equal (non-inferior) with regards to efficacy and safety in comparison with a clinically well-established PTX coated balloon.

The objective of this prospective, randomized, multi-center, post-market study is to compare the Magic Touch Sirolimus DCB with Paclitaxel-coated DCB for treatment of high grade ste-notic or occluded lesions in SFA and / or P1 segment of the popliteal artery (PA) in PAD pa-tients.

Inclusion Criteria:

1. Subject age ≥ 18
2. Subject has been informed on the nature of the study, the duration of the study, agrees to attend follow-up visits, agrees to complete the required testing, agrees to participate, and has signed an informed consent form.
3. Rutherford category 2-4 according to the investigator's subjective evaluation
4. Subject has a de novo or re-stenosed lesion with ≥ 70 % stenosis documented angiographically
5. Target lesion length is ≥ 2 cm and ≤ 20 cm by visual estimate of the treating physician
6. Multiple lesions with max. 3 cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion. Total lesion length should not exceed 20 cm
7. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
8. Patency of P2 and P3 segment of the popliteal artery and at least one (1) infrapopliteal artery to the ankle (< 50 % diameter stenosis) in continuity with the femoropopliteal artery
9. Patency of ipsilateral iliac artery (≤ 30% diameter stenosis). Iliac artery stenosis > 30 % may be treated during the index procedure to ensure sufficient inflow.
10. A guidewire has successfully traversed the target treatment segment intraluminal
11. Vascular disease in the opposite leg that requires treatment at the time point of index procedure is allowed, but has to be treated according to randomization or with POBA.
12. A patient can only be enrolled and randomized once with only one target lesion in the SIRONA trial. Please note that only the lesion in one limb can be treated as target lesion for index procedure.

Exclusion Criteria:

1. Failure to successfully cross the target lesion or subintimal target lesion guidewire crossing
2. Flow-limiting dissection after pre-dilatation
3. Angiographic evidence of severe calcification of the target vessel (contiguous calcification on both sides of the vessel)
4. Presence of fresh thrombus in the target lesion
5. Presence of aneurysm in the target vessel/s
6. Prior vascular surgery (including atherectomy, bypass surgery) of the target limb
7. Prior stent in the target lesion
8. Stroke or heart attack within 3 months prior to enrollment
9. Any vascular surgical procedure or intervention performed in the target limb within 30 days prior to or planned within 30 days post index procedure
10. Any vascular treatment with PTX or sirolimus-coated devices 60 days prior to index procedure
11. Target lesion requires treatment with alternative therapies such as primary stenting, laser, lithotripsy, thrombectomy, atherectomy, cryoplasty, brachytherapy, re-entry devices
12. Enrolled in another investigational drug, device or biologic study
13. Life expectancy of less than one year in the investigator's opinion
14. Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, sirolimus, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
15. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
16. Receiving dialysis or immunosuppressant therapy
17. Pregnant or lactating females
18. History of major amputation in the same limb as the target lesion