Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease

Inclusion Criteria:

1. Age ≥ 21 years or minimum age

2. Rutherford class 3 to 6 in the target limb Intraoperative Inclusion Criteria

3. Single or sequential de novo or re-stenotic lesions (stenosis of > 50% orocclusions) from 2 to 20cm in the femoropopliteal arteries. Lesion is considered asone lesion if there is maximum of 30mm gap between lesions at discretion ofinvestigator. Femoropopliteal arteries are superficial femoral artery, poplitealartery P1 and P2

4. Inflow free from flow limiting lesions (<50% stenosis) confirmed by duplex orangiography. Subjects with flow limiting inflow lesions (>50% stenosis) can beincluded if lesion had been treated successfully (<30% residual stenosis) before orduring the index procedure.

5. At least one non-occluded crural vessel (ie. without significant stenosis) withangiographically documented run off to the foot.

Exclusion Criteria:

1. Comorbid conditions limiting life expectancy ≤ 1 year

2. Subject is currently participating in another investigational drug or device studythat has not reached first primary endpoint yet

3. Subject is pregnant or planning to become pregnant during the course of the study

4. Heel gangrene

5. Prior bypass surgery of target vessel

6. Planned amputation of the target limb

7. Previously implanted stent in the target lesion

8. Vulnerable or protected adults

9. Bleeding diathesis or another disorder such as gastrointestinal ulceration whichrestrict the use of clopidogrel or aspirin

10. Known allergy to sirolimus Intraoperative Exclusion Criteria

11. Failure to successfully cross the target lesion with a guide wire (successfulcrossing means tip of the guide wire distal to the target lesion in the absence offlow limiting dissections or perforations)

12. Failure to obtain <30% residual stenosis in a pre-existing lesion

13. Highly calcific lesions

14. Use of DCBs, drug eluting stent, specialty balloons or artherectomy devices duringthe index procedure. (Non-compliant balloons are not considered specialty balloons)

15. Lesions requiring retrograde access (SAFARI)