Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia

Phase 4

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Device: PTA; Device: DEB

• Registration Number: NCT02563535
• Lead Sponsor: Ospedale San Donato

Brief Summary

The aim of this study is to evaluate the potential advantage in terms of late lumen loss reduction of Litos drug-eluting balloon vs standard percutaneous transluminal angioplasty in the treatment of below-the-knee disease in patients with critical limb ischemia.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-27
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-30
• Status Verified: 2020-01
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• age>18 years
• critical limb ischemia (Rutherford class 4-6)
• angiographic stenosis>50% or occlusion of at least one tibial vessel of at least 40mm for which an interventional treatment is scheduled

Exclusion Criteria

• need for major amputation known before intervention
• allergy to Paclitaxel
• contraindication for combined antiplatelet treatment
• life expectancy <1 year
• hypersensitivity or contraindication to one of the study drugs
• lack of consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional PTA	PTA	angioplasty with conventional balloon
Drug-eluting balloon	DEB	angioplasty with Litos drug-eluting balloon

Primary Outcome Measures

Name	Time	Method
Late Lumen Loss (LLL) in the target lesion documented by angiography	6 months	Late Lumen Loss (LLL) in the target lesion documented by angiography

Secondary Outcome Measures

Name	Time	Method
Number of events of angiographic occlusive restenosis	6 months	number of events of angiographic occlusive restenosis
Number of events of target lesion revascularization (TLR)	12 months	number of events of target lesion revascularization

Trial Locations

Locations (1)

Cardiovascular Department, Ospedale S.Donato; 🇮🇹 Arezzo, AR, Italy