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DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia

Peripheral Vascular Diseases Clinical Trial

Official title:
Randomized Trial Comparing Drug Coated Balloon vs Plain Balloon Angioplasty in Critical Limb Ischemia and Treatment of Long Lesions in Crural Arteries

Clinical Trial Summary

The purpose of this trial is to compare short- medium long-term results in treatment of PAD (peripheral arterial disease) in the crural arteries with either drug coated balloon or conventional balloons in a prospective , randomized, single center study Results will be defined as: Limb salvage, Event-free survival, Freedom from TLR (target lesion revascularization), Primary patency, Clinical success, Serious adverse events, and the patients will be followed-up for 1 years. Primary endpoints: Primary Patency at 12 months, TLR (clinical driven), Secondary endpoints: Event free survival, Clinical success at 6,12 months, Technical success, Serious adverse events,

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02750605
Study type Interventional
Source Skane University Hospital
Contact
Status Completed
Phase N/A
Start date February 2016
Completion date August 30, 2022
View Details
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