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

NCT ID: NCT02212470

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2019-10-31

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.

Conditions

Peripheral Arterial Disease; Arterial Occlusive Diseases; Atherosclerosis; Arteriosclerosis; Cardiovascular Diseases; Peripheral Vascular Diseases; Paclitaxel; Plaque, Atherosclerotic; Critical Limb Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Drug Eluting Balloon

Admiral In.Pact Drug Eluting Balloon

Group Type: ACTIVE_COMPARATOR

Drug Eluting Balloon Angioplasty

Intervention Type: DEVICE

Angioplasty with Drug eluting balloon after pre dilatation

Nitinol Stent

Complete SE Self-expandible Nitinol stent

Group Type: ACTIVE_COMPARATOR

Nitinol stenting

Intervention Type: DEVICE

Nitinol stent deployment

Interventions

Drug Eluting Balloon Angioplasty

Angioplasty with Drug eluting balloon after pre dilatation

Intervention Type: DEVICE

Nitinol stenting

Nitinol stent deployment

Intervention Type: DEVICE

Other Intervention Names

Medtronic; Admiral In.Pact; Medtronic; Complete SE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Instituto Dante Pazzanese de Cardiologia

OTHER

Sponsor Role: lead

Responsible Party

Fabio H Rossi

MD, PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

BRUNO L ALMEIDA, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardiologia

FABIO H ROSSI, MD, PHD

Role: STUDY_DIRECTOR

Instituto Dante Pazzanese de Cardiologia

Locations

Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Countries

Brazil

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Other Identifiers

IDPC_3 2014

Identifier Type: -

Identifier Source: org_study_id