NCT01983449

Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease

Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Mercator MedSystems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peripheral Arterial Diseases

Interventions

Type	Name	Description
DRUG	Dexamethasone Sodium Phosphate Injection, USP	Adventitial infusion of dexamethasone after angioplasty or atherectomy-based revascularization of the superficial femoral or popliteal artery.

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-12-01
• Completion: 2018-01-01
• First posted: 2013-11-14
• Last updated: 2018-03-08

Locations

38 sites across 1 country: United States