COMPLIANCE 360° Feasibility Study

First-of-its-Kind Randomized Trial in Peripheral Anatomy
Orbital PAD Treatment Versus Balloon Angioplasty in Calcified Infrapopliteal Lesions

Study Overview

Evaluates the clinical benefit of altering lesion compliance with the Diamondback 360° + low-pressure balloon angioplasty to high-pressure balloon angioplasty alone in calcified femoral-popliteal vessels.

Primary Endpoint: Freedom from target lesion revascularization, including the need for bailout stenting and restenosis (peak systolic velocity ratio =2.5) at six months

Enrollment complete
Patients will be followed at 6 & 12-months
Acute results forthcoming

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Disclosure: The Diamondback 360^® PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The System is contraindicated for use in coronary arteries, bypass grafts, stents, or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.

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COMPLIANCE 360° Feasibility Study

First-of-its-Kind Randomized Trial in Peripheral AnatomyOrbital PAD Treatment Versus Balloon Angioplasty in Calcified Infrapopliteal Lesions

Study Overview

First-of-its-Kind Randomized Trial in Peripheral Anatomy
Orbital PAD Treatment Versus Balloon Angioplasty in Calcified Infrapopliteal Lesions