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

In patients with infrainguinal arterial disease, can the Chocolate Balloon Catheter be used safely and effectively for ballon dilatation during percutaneous transluminal revascularization procedures?

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000771055

Acronym

Chocolate FIM

Enrollment

Registered

2010-09-15

Start date

2010-11-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is intended to evaluate the use of the Chocolate Balloon Catheter to treat arterial disease in the infrainguinal arteries.

Interventions

Percutaneous Transluminal Angioplasty (PTA)- During this procedure a balloon, such as the Chocolate Balloon, is placed across a narrowing in a blood vessel of the leg. The balloon is inflated temporarily to open up the narrowing by pushing on the wall of the vessel to restore blood flow in that part of the artery. After inflation, the balloon is removed and no part of the balloon catheter is left behind in the artery. The balloon can be inflated for up to a few minutes and it may be inflated

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results