DiRectional AthErectomy + Drug CoAted BaLloon to Treat Long, CalcifIed FemoropopliTeal ArterY Lesions (REALITY)

This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Atherectomy, Drug-Coated Balloon Read More

Inclusion Criteria:

General Inclusion Criteria:

1. Willing and able to provide informed consent;
2. Age ≥ 18 years of age;
3. Clinical evaluation determines Rutherford Category 2-4;
4. Willing to comply with all study requirements;
5. All lab work is within acceptable limits to undergo a percutaneous interventional procedure.
6. Life expectancy, in the investigator's opinion, of at least 24 months.

Angiographic Inclusion Criteria:

1. RVD ≥ 4mm and ≤ 7mm;
2. Evidence of a ≥70% de novo or restenotic lesion or occlusion in the target lesion defined as in the superficial femoral artery and/or popliteal artery, located in the arterial segment starting at least 1 cm beyond the Common Femoral Artery (CFA) bifurcation between the superficial and profunda femoris arteries (proximal anatomical landmark) to the distal P2 segment of the popliteal artery;

3. Total lesion/occlusion length:

   a. ≥ 8 cm and ≤ 18 cm

4. Total occlusion length

   a. ≥ 6 cm and ≤10 cm

5. Stenosis or occlusion begins 1cm below the profunda-SFA bifurcation;
6. Femoral or popliteal stenosis or occlusion that does not extend beyond the P2 popliteal segment;
7. Minimum 1 patent infrapopliteal vessel to the foot with ≤ 50% diameter stenosis;
8. Grade 3 or 4 intimal, medial and/or mixed calcification per the PACSS as judged by the operator at the time of the procedure;

9. Index lesion fits within guidelines below:

   9.1 If two lesions are ≤ 3 cm apart, treatment would be allowed as a single lesion providing they contain a segment of moderate or severe calcification and the total lesion length is ≥ 8 cm and ≤18 cm.

   9.2 If more than one lesion is within the target vessel, and they are separated by > 3 cm of normal vessel, one lesion must be designated by the investigator as the target lesion as long as the lesion meets all angiographic eligibility criteria. Only one index lesion is permitted for analysis, but study will allow a second lesion to be treated as a non-target lesion.

10. Infrapopliteal lesion, if diagnosed, can be staged and treated > 30 days after index procedure.

Exclusion Criteria:

General Exclusion Criteria:

1. Renal failure or chronic kidney disease with GFR ≤30 ml/min or MDRD GFR ≤30 ml/min per 1.73m2 (and serum creatinine ≥2.5 mg/dL within 30 days of index procedure);
2. Physician does not believe subject is an appropriate candidate for study;
3. Previous infra-inguinal intervention in the index limb within 30 days of the planned femoropopliteal intervention

Angiographic Exclusion Criteria:

1. Inability to cross lesion/occlusion with a guidewire or re-entry device;
2. Inability for the guidewire to re-enter and/or remain in the true lumen prior to enrollment;
3. In-stent restenosis of the target lesion, or recognition of any stent (patent or re-stenotic within the femoropopliteal segment of the index limb;
4. Aneurysm located in the target vessel or aneurysmal vessel;
5. Acute thrombus in the index limb prior to enrollment.