drugset / Trial / NCT02807779
Intima Versus Adventitia Drug Delivery to Elucidate Mechanisms of Restenosis: Magnetic Resonance Imaging
Phase 4
Completed
33 enrolled
University of California, San Francisco
National Heart, Lung, and Blood Institute (NHLBI) · collabUniversity of Washington · collab
RandomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2016-02-10
- Primary completion
- 2020-10-31
- Completion
- 2022-10-31
Outcome
Missed primary endpoint
registry analysis (superiority test); Dexamethasone vs Drug-Coated Balloon; p = 0.22; t-test, 2 sided NCT02807779 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | — | Other |