Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery

Phase 4

Completed

• Conditions: Peripheral Arterial Disease; Arterial Occlusive Diseases; Atherosclerosis; Plaque, Atherosclerotic; Arteriosclerosis; Peripheral Vascular Diseases; Paclitaxel; Critical Limb Ischemia; Cardiovascular Diseases
• Interventions: Device: Drug Eluting Balloon Angioplasty; Device: Nitinol stenting

• Registration Number: NCT02212470
• Lead Sponsor: Instituto Dante Pazzanese de Cardiologia

Brief Summary

The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-08
• Primary Completion: 2018-12
• Study Completion: 2019-10
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Patients over 18 years with critical lower limb ischemia,
• Ruhtherford 3 or higher,
• with angiographic documentation of greater than 70% or occlusion in the superficial femoral artery,
• with a maximum extension of 10 cm stenosis.
• The popliteal artery and at least one leg artery must be patent.

Exclusion Criteria

• Pregnancy,
• thrombophilia,
• coagulation disorders,
• presence of active or recent bleeding,
• severe allergy to iodinated contrast,
• renal or hepatic disease,
• acute limb ischemia,
• prior surgical bypass or angioplasty (with or without stent) on the target artery,
• obstructive disease (stenosis> 50%) of the aortoiliac segment ipsilateral to the target (if the aortoiliac is pre-treated, the patient may be included)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Eluting Balloon	Drug Eluting Balloon Angioplasty	Admiral In.Pact Drug Eluting Balloon
Nitinol Stent	Nitinol stenting	Complete SE Self-expandible Nitinol stent

Primary Outcome Measures

Name	Time	Method
Primary patency	12 months	Evaluations will be conducted after 3, 6 and 12 months of the procedure. The ultrasonographic evaluation of the degree of stenosis will use the Systolic Velocity Index (division of the velocity of flow at the point of greatest stenosis by the velocity of flow in normal prior segment). Rates higher than 2.4 indicate stenosis greater than 50%

Secondary Outcome Measures

Name	Time	Method
Death	12 months	Death rate evaluated in 3, 6 and 12 months
Acute myocardial infarct	12 months	Acute myocardial infarct rate evaluated in 3, 6 and 12 months
Ankle braquial Index	12 months	Change in the Ankle braquial Index evaluated in 3, 6 and 12 months
Target Lesion Revascularization	12 months	Target Lesion Revascularization rate evaluated in 3, 6 and 12 months
Rutherford classification	12 months	Change in classification from Rutherford evaluated in 3, 6 and 12 months.
Stent fracture	12 months	Stent fracture rate evaluated in 3, 6 and 12 months
Amputation	12 months	Major amputation defined as amputation that requires prosthesis

Trial Locations

Locations (1)

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 Sao Paulo, Brazil