First-in-human Evaluation of the SELUTION DCB, a Novel Sirolimus Coated Balloon in Peripheral Arteries

SELUTION™ Sirolimus Coated PTA Balloon Catheter Prospective, Controlled, Multi-Center, Open, Single-Arm Clinical Investigation for the Treatment of Patients With Femoropopliteal Artery Lesions With a Novel Drug Coated Balloon

The primary objective of the Clinical Investigation is to assess the clinical safety and the inhibition of restenosis of the Investigational Device in the treatment of de-novo occluded/stenotic or re-occluded/restenotic lesions of the superficial femoral and/or popliteal arteries.

The primary endpoint of the Clinical Investigation is Late Lumen Loss (LLL) of the target lesion, as measured by Quantitative Vascular Angiography (QVA) at 6 months post-index procedure.

Inclusion Criteria:

1. Patients who are mentally and linguistically able to understand the aim of the Clinical Investigation and to show sufficient compliance in following the Clinical Investigation Plan.
2. Patients must agree to return for all required post-index procedure follow-up visits.
3. Patients are able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of the Clinical Investigation. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
4. Patients have a documented diagnosis of Peripheral Arterial Disease (PAD) classified as Rutherford class 2-3-4 in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA). Patients with a documented diagnosis of PAD classified as Rutherford class 2, may only be included in case conservative and medicinal treatment have proved ineffective in these patients.
5. Patients are able to walk without assistive devices such as walker or cane.
6. Patients are eligible for peripheral revascularization by means of PTA.
7. The target vessel reference diameter must be ≥ 3.0 and ≤ 7.0 mm.
8. The target lesion length must be ≤ 15 cm and stenosed or occluded.
9. The target lesion must be in a native, non-stented SFA and/or PA target vessel and located ≥ 1 cm below the Common Femoral Artery (CFA) bifurcation and terminate distally ≥ 1 cm above the origin of the Tibial-Peroneal (TP) trunk.
10. Treatment of multiple target lesions is allowed, as long as the composite target lesion length is ≤ 15 cm and the target lesions can be treated with a maximum of 2 overlapping Investigational Devices.
11. The target lesion must either be de-novo or restenotic (stenosis ≥ 70% diameter reduction or occlusion by visual estimate). If the target lesion is restenotic, the prior PTA must have been done > 30 days prior-index procedure.
12. The target lesion must have been successfully crossed with a guide wire and there must be successful pre-dilatation of the target lesion, in the absence of early recoil, significant remaining stenosis or flow-limiting dissection.
13. There must be a patent (< 50% stenosis) inflow artery, as confirmed by angiography. Treatment of inflow disease during the index procedure is allowed. Patients with flow-limiting inflow lesions can be included, if inflow lesions have been treated (use of DES or DCB not allowed) successfully (attainment of residual diameter stenosis ≤ 30% without major vascular complications).

There must be at least 1 patent (< 50% stenosis) native outflow artery to the ankle, as confirmed by angiography. Treatment of outflow disease during the index procedure is NOT permitted.

Exclusion Criteria:

1. Patients with a known hypersensitivity or contraindication to aspirin, heparin, other anticoagulant/anti-platelet therapies, Sirolimus (or analogs) or sensitivity to contrast media that cannot be adequately pre-medicated.
2. Patients with an obligatory need of cumarine or other anticoagulants (e.g. Novel Oral Anticoagulant (NOAC) drugs).
3. Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the Investigational Device.
4. Patients with a life expectancy, from the Investigator's opinion, of less than 3 years.
5. Patients that are currently participating in other clinical investigations involving any investigational drug or device that may potentially confound the results of the Clinical Investigation, or that would limit the patient's compliance with the follow-up requirements of the Clinical Investigation.
6. Patients with a history of Myocardial Infarction (MI), thrombolysis or angina within 30 days prior-index procedure.
7. Patients with a history of major disabling stroke within 3 months prior-index procedure.
8. Patients with any type of previous or planned surgical or interventional procedure within 15 days prior- and/or within 30 days post-index procedure.
9. Patients with a presence or history of severe renal failure (Glomerular Filtration Rate (GFR) ≤ 30 ml/min).
10. Patients who have undergone prior vascular surgery of the SFA and/or PA in the index limb to treat atherosclerotic disease.
11. Patients with clinically significant aneurysmal disease of the iliac, femoral or popliteal artery and patients with a history of clinically significant abdominal aortic aneurysm.
12. Treatment of the contralateral limb during the same index procedure or within 30 days post-index procedure in order to avoid confounding complications.
13. Patients under administrative or judicial custody (§20 Act on Medical Devices, Germany).
14. Composite target lesion length is > 15 cm.
15. Treatment of target lesion(s) that requires more than 2 overlapping Investigational Devices.
16. A COMPLIANCE360-Score of 3 or higher, showing a (moderately) severe circumferentially calcified target lesion as displayed on plain x-ray prior to the index procedure expected for early recoil and imperative need of plaque modulation or stenting as judged by the investigator prior to pre-dilatation.
17. Significant inflow disease or treatment of inflow disease during index procedure not successful.
18. Known inadequate distal outflow (> 50 % stenosis of distal popliteal and/or all three tibial vessels), or planned treatment of vascular disease distal to the target lesion post-index procedure.
19. Known required use of adjunctive treatment modalities (laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.).

Remaining acute or sub-acute thrombus in the target vessel.