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Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging

NCT02807779 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-07-17

Study results available
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Summary

This is a prospective, multicenter, randomized trial to determine the mechanisms of vascular healing. The study will evaluate subjects with peripheral artery disease (PAD) who require an endovascular intervention of the femoro-popliteal (SFA) artery to restore blood flow to the leg.

Conditions

Interventions

DRUG

Dexamethasone infusion

Participants will receive dexamethasone infusion following plain balloon angioplasty

DEVICE

Drug coated balloon

Participants will receive angioplasty with a drug-coated balloon following plain balloon angioplasty

DEVICE

Plain balloon angioplasty

Participants will receive plain balloon angioplasty only

Sponsors & Collaborators

Principal Investigators

  • Warren Gasper, MD · San Francisco VA Medical Center

  • David Saloner, PhD · San Francisco VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-10
Primary Completion
2020-10-31
Completion
2022-10-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807779 on ClinicalTrials.gov