Evaluation of the Chocolate Balloon Catheter for Percutaneous Transluminal Revascularization of Infrainguinal Arterial Disease

Not Applicable

• Conditions: Arterial disease of the infrainguinal arteries; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12610000771055
• Lead Sponsor: Quattro Vascular Pte Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Intermittent claudication or critical limb ischemia (Rutherford 2-5)
De novo or restenotic stenosis (=50%) or occlusion in the infrainguinal arteries, including superficial femoral artery (SFA), popliteal, and infrapopliteal arteries
Reference vessel diameter 2.0-6.0 mm
Lesion length =150mm
Lesion must be successfully crossed with a guidewire

Exclusion Criteria

Acute limb ischemia
Non-atherosclerotic disease (e.g. embolism, Buerger's disease, vasculitis)
Patient requires any concomitant percutaneous endovascular procedure in other vasculature e.g. renal, coronary, carotid, etc.
Myocardial infarction or stroke within 30 days prior to the procedure
Any planned surgical intervention/procedure within 30 days of the study procedure
In-stent restenosis proximal to or in the target lesion
Target lesion distal to a newly implanted stent

Study & Design

• Study Type: Interventional
• Study Design: Not specified