Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral Arterial Revascularization

Completed · Not applicable

Conditions studied: Peripheral Artery Disease

In brief

To evaluate the safety and effectiveness of the Revolution™ Peripheral Atherectomy System in the treatment of infrainguinal lower extremity peripheral arterial occlusive disease. This Atherectomy system will be used on eligible patients with stenosis of at least 70% diameter reduction to evaluate the change in stenosis after the procedure (effectiveness) and the presence of any major adverse events (safety) for up to 30 days after the procedure.

Key facts

Study ID

NCT02961894

Run by

Rex Medical

People needed

121

Starts

2017-06-07

Expected to finish

2019-09-20

Last updated by the study team

2020-11-02

Who can join

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

You may qualify if…

• Age ≥ 18 years;
• Willing and able to provide informed consent.
• Ability to take at least one form of anti-platelet therapy.
• Rutherford categories 2 to 5 in the target limb.
• Lesions to be treated with the study device must be located in the same limb.
• Target lesion(s) located within the superficial femoral, popliteal or tibial arteries.
• Target lesion(s) with stenosis ≥70% diameter reduction as measured by site-reported angiography.
• Target lesion length(s) ≤150 mm.
• Target lesions(s) with reference vessel diameter (proximal and distal to target lesion) ≥2.0 mm and ≤4.0 mm.

You may not qualify if…

• Subjects in whom amputation above the ankle is necessary, irrespective of the success of revascularization.
• In-stent restenosis within the target lesion.
• Flow-limiting dissection, Type C or greater.
• Target lesions within an autogenous or prosthetic bypass graft.
• History of an endovascular procedure or open vascular reconstruction in the index limb within the last 30 days, including thrombolytic therapy.
• Any open vascular surgical procedure planned in the target limb or endovascular procedures planned in the target vessel within 30 days after the index procedure.
• Kidney disease of sufficient severity, in the Investigator's opinion, to contraindicate lower extremity angiography using standard or alternate contrast agents as per the local Standard of Care.
• Pregnancy or breast feeding. A woman of child-bearing potential must have a negative pregnancy test within one week of index procedure.
• Myocardial infarction or stroke within 2 months of enrollment.
• Contraindication to antiplatelet, anticoagulant, or thrombolytic therapy.
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count < 125,000/μL, known coagulopathy, or INR > 1.5.
• Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pretreated in the opinion of the investigator.
• History of heparin-induced thrombocytopenia.
• Psychiatric disorder which, according to the investigator, has potential to interfere with provision of informed consent, completion of tests, therapy, or follow-up.
• Clinical/angiographic evidence of distal embolization or acute thrombus.
• Significant stenosis (>50% diameter reduction) or occlusion of inflow vessels that was not successfully treated (<50% residual stenosis without flow limiting dissection) before the study intervention.

Where it is running

• Vascular Breakthroughs — Darien, Connecticut, United States
• First Coast Cardiovascular Institute — Jacksonville, Florida, United States
• Precision Clinical Research — Lauderdale Lakes, Florida, United States
• Coastal Vascular and Interventional — Pensacola, Florida, United States
• St. Joseph's Hospital — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Community Health — Munster, Indiana, United States
• Michigan Outpatient Vascular Institute — Dearborn, Michigan, United States
• Vascular Access Center — Mays Landing, New Jersey, United States
• North Carolina Heart and Vascular — Raleigh, North Carolina, United States
• Allegheny Vein & Vascular — Bradford, Pennsylvania, United States
• Capital Area Research, LLC — Camp Hill, Pennsylvania, United States
• Pennsylvania Vascular Institute — Philadelphia, Pennsylvania, United States
• Anderson Heart — Anderson, South Carolina, United States
• DFW Vascular Group — Dallas, Texas, United States
• Houston Heart and Vascular — Kingwood, Texas, United States
• Cardiovascular Associates of East Texas — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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