NCT01763476

Atherectomy and Drug-Coated Balloon Angioplasty in Treatment of Long Infrapopliteal Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Herz-Zentrums Bad Krozingen · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number of these patients could be helped through medication or surgery. In fact within the first year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90% have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of cases 3 months after index procedure. Even the use of drug-eluting balloons leads only to 1-year primary patency rates up to 30%. The primary objective of this study is to compare the performance of atherectomy followed by a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo infrapopliteal lesions in a prospective, single-center, randomized clinical trial.

Detailed description

This is a single-centre, prospective, randomized study to be conducted in Bad Krozingen (Germany). A total of 80 subjects will be entered into the study and will be randomized on a 1:1 basis to either drug-coated balloon angioplasty or atherectomy and drug-coated balloon angioplasty for infrapopliteal use in subjects with long de-novo stenosis (≥6cm) and symptomatic peripheral artery disease (Rutherford 3, 4, or 5). IVUS of the target lesion prior and after intervention will be performed in 15 patients of each group during index procedure. All subjects will undergo a repeat angiography at 3 months to assess the primary endpoint of In-Segment Binary Restenosis. Follow-up visits are scheduled at 3, 6, 12 months.

Conditions

• Peripheral Artery Disease
• Occlusion of Artery

Interventions

Type	Name	Description
PROCEDURE	paclitaxel-coated balloon angioplasty	plain balloon angioplasty followed by paclitaxel-coated balloon angioplasty of the target lesion
PROCEDURE	atherectomy	atherectomy (TurboHawk, ev3) followed by paclitaxel-coated balloon angioplasty of the target lesion

Timeline

• Start date: 2013-01-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2013-01-09
• Last updated: 2018-08-03

Locations

1 site across 1 country: Germany