NCT03942601

Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Mercator MedSystems, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, pilot feasibility study to document the effects of adventitial delivery of temsirolimus or temsirolimus with dexamethasone sodium phosphate injection, USP, after revascularization of femoropopliteal lesions in symptomatic patients with moderate to severe claudication (Rutherford 2-3) or critical limb ischemia (CLI) with rest pain (Rutherford 4). Subjects will be followed for up to 60 months post index procedure.

Detailed description

To begin to assess the safety and effectiveness of Bullfrog Micro-Infusion Device adventitial deposition of temsirolimus or temsirolimus with dexamethasone in maintaining luminal patency and composite safety endpoints in patients with clinical evidence of moderate to severe claudication or critical limb ischemia with rest pain after revascularization of one or more angiographically significant lesion(s) in superficial femoral or popliteal arteries.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DRUG	Temsirolimus	Temsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1
DRUG	Temsirolimus and dexamethasone sodium phosphate	Temsirolimus Injection (0.4 mg/mL), Dexamethasone Sodium Phosphate Injection, USP (3.2 mg/mL) and 20% contrast in Group 2

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2019-05-08
• Last updated: 2024-07-10

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study