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

Completed · Not applicable

Conditions studied: Peripheral Vascular Disease

In brief

This study is designed to collect information during a procedure that is routine care for treating a blockage in a blood vessel in the upper part of the participant's leg. This study is for data collection reasons to help doctors gain better understanding of the treatment of disease in the blood vessels of the legs. You will be treated with two devices that are routine, or standard of care, for your doctor to treat blockages in the blood vessel of the leg. The treatment is for a blockage or narrowing caused by plaque build-up in the blood vessel. Data will be collected to assess what length of time the blood vessel will be prevented from re-narrowing through twenty-four (24) months after the procedure.

Key facts

Study ID

NCT02850107

Run by

VIVA Physicians

People needed

102

Starts

2016-06-01

Expected to finish

2020-06-16

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• General Inclusion Criteria:
• Willing and able to provide informed consent;
• Age ≥ 18 years of age;
• Clinical evaluation determines Rutherford Category 2-4;
• Willing to comply with all study requirements;
• All lab work is within acceptable limits to undergo a percutaneous interventional procedure.
• Life expectancy, in the investigator's opinion, of at least 24 months.
• Angiographic Inclusion Criteria:
• RVD ≥ 4mm and ≤ 7mm;
• 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;
• Total lesion/occlusion length:
• a. ≥ 8 cm and ≤ 18 cm
• Total occlusion length
• a. ≥ 6 cm and ≤10 cm
• Stenosis or occlusion begins 1cm below the profunda-SFA bifurcation;
• Femoral or popliteal stenosis or occlusion that does not extend beyond the P2 popliteal segment;
• Minimum 1 patent infrapopliteal vessel to the foot with ≤ 50% diameter stenosis;
• Grade 3 or 4 intimal, medial and/or mixed calcification per the PACSS as judged by the operator at the time of the procedure;
• Index lesion fits within guidelines below:
• 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.
• 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.
• Infrapopliteal lesion, if diagnosed, can be staged and treated > 30 days after index procedure.

You may not qualify if…

• General Exclusion Criteria:
• 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);
• Physician does not believe subject is an appropriate candidate for study;
• Previous infra-inguinal intervention in the index limb within 30 days of the planned femoropopliteal intervention
• Angiographic Exclusion Criteria:
• Inability to cross lesion/occlusion with a guidewire or re-entry device;
• Inability for the guidewire to re-enter and/or remain in the true lumen prior to enrollment;
• In-stent restenosis of the target lesion, or recognition of any stent (patent or re-stenotic within the femoropopliteal segment of the index limb;
• Aneurysm located in the target vessel or aneurysmal vessel;
• Acute thrombus in the index limb prior to enrollment.

Where it is running

• Iowa Methodist Medical Center — Des Moines, Iowa, United States
• St. Elizabeth's — Boston, Massachusetts, United States
• University of Mississippi — Jackson, Mississippi, United States
• Mount Sinai — New York, New York, United States
• Rex — Raleigh, North Carolina, United States
• Austin Heart — Austin, Texas, United States
• Longview Cardiac and Vascular Consultants — Longview, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.