NCT02750605

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Skane University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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,

Conditions

• Peripheral Vascular Diseases

Interventions

Type	Name	Description
DEVICE	DEB	Intervention with drug eluting balloon.
DEVICE	POBA	Intervention with old technology as comparison

Timeline

• Start date: 2016-02-01
• Primary completion: 2021-04-30
• Completion: 2022-08-30
• First posted: 2016-04-25
• Last updated: 2022-12-30

Locations

1 site across 1 country: Sweden