At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 33 enrolled

Drug / intervention

Dexamethasone infusion +2 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02807779

NCT02807779Phase 4Completed

Compare CT.gov

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

University of California, San Francisco·interventional·Posted Jun 21, 2016·Updated Jul 17, 2025

In Brief

A Phase 4 clinical trial evaluating Dexamethasone infusion, Drug coated balloon, and 1 other intervention for Peripheral Artery Disease and 2 related conditions. Completed, enrolled 33 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPeripheral Artery Disease, Vascular Disease, Critical Limb Ischemia

CountriesUnited States

CollaboratorsUniversity of Washington, National Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 4CompletedFinished

20162017201820192020202120222023202420252026

Enrollment StartFeb 2016

First PostedJun 2016

Primary CompletionOct 2020

Study CompletionOct 2022

TodayJul 2026

First PostedJun 21, 2016

Enrollment StartFeb 10, 2016

Primary CompletionOct 31, 2020

Study CompletionOct 31, 2022

TodayJul 2, 2026

Enrollment to primary: 4.7 yearsPosted 10.0 years ago

Interventions

Dexamethasone infusiondrug

Participants will receive dexamethasone infusion following plain balloon angioplasty

Drug coated balloondevice

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

Plain balloon angioplastydevice

Participants will receive plain balloon angioplasty only