Peripheral Arterial Diseases Clinical Trial
Official title:
Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization
To assess the safety and effectiveness of adventitial deposition of the Study Drug in
reducing inflammation and restenosis in patients with clinical evidence of claudication or
critical limb ischemia and an angiographically significant lesion in the superficial femoral
and/or popliteal arteries.
Study Drug and Dose: Dexamethasone Sodium Phosphate Injection, USP, 4 mg/ml, with dilute
contrast (17%) administered to the adventitia in a dose of 1.6 mg per cm of desired vessel
treatment length.
This trial will examine the ability for adventitial dexamethasone to safely delay restenosis in patients at least 18 years of age, who have peripheral atherosclerotic lesions involving the superficial femoral and/or popliteal arteries. These patients have no current therapeutic alternatives beyond the procedure used to open, or revascularize, their superficial femoral and/or popliteal arteries. Metal stents have the potential to fracture when implanted in this artery segment due to continual flexion and bending of the knee. It is desirable to improve the patency of this artery after percutaneous transluminal angioplasty (PTA) and/or atherectomy-based revascularization. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02041169 -
Lower Extremity Peripheral Arterial Disease and Exercise Ischemia
|
N/A | |
| Completed |
NCT01436435 -
The Jetstream (JET) Post-market Registry
|
Phase 4 | |
| Completed |
NCT03469349 -
Actovegin 12-Week Treatment Given First Intravenously and Subsequently Orally in Participants With Peripheral Arterial Occlusive Disease Fontaine Stage IIB
|
Phase 3 | |
| Completed |
NCT00640770 -
Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease
|
Phase 4 | |
| Recruiting |
NCT05192707 -
Transcutaneous Oxygen Pressure (TcPO2) Determination.
|
||
| Withdrawn |
NCT02531139 -
The Effect of Blood Pressure on Cerebral Perfusion During Vascular Surgery
|
N/A | |
| Completed |
NCT00652418 -
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography
|
Phase 2 | |
| Completed |
NCT02920125 -
Study the Result of Ayurvedic SUVED & Reimmugen (Colostrum) Treatment on Vascular Disease, CAD, CVA, DVT.
|
Phase 3 | |
| Completed |
NCT02273232 -
Effects of Remote Ischemic Preconditioning on Moderate PVD Patients A Pilot Randomized Control Trial
|
Phase 1 | |
| Completed |
NCT01952756 -
Effect of Cilostazol Endothelial Progenitor Cells and Collateral Formation in Peripheral Occlusive Artery Disease (PAOD)
|
Phase 4 | |
| Completed |
NCT01419418 -
Patients' Perspectives of Factors That Support the Management of Peripheral Arterial Disease for Improved Outcomes
|
N/A | |
| Completed |
NCT02066740 -
EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study
|
N/A | |
| Completed |
NCT01336101 -
Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent
|
N/A |