NCT01099215

Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH)

An Open-Label Dose Escalation Safety Study of PVS-10200 for the Treatment of Restenosis in Patients Undergoing Minimally Invasive Peripheral Revascularization (TRIUMPH)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of two doses of PVS-10200, an allogeneic cellular therapy, delivered as a single injection following percutaneous transluminal ("balloon") angioplasty and stent placement for the treatment of peripheral artery disease (PAD).

Detailed description

This is an open-label dose escalation safety study of PVS-10200 in 30 subjects with peripheral artery disease (PAD) requiring balloon angioplasty and stent placement in the superficial femoral artery (SFA). The study will be completed sequentially in two dose cohorts of 10 subjects (low dose group, Cohort A) and 20 subjects (high dose group, Cohort B). A Data Safety Monitoring Board (DSMB) will conduct regular safety reviews. Each subject will receive one treatment of PVS-10200 delivered by ultrasound guided injection to the perivascular region (external to the vessel) of the stented target lesion. The treatment will be administered within 24 hours after balloon angioplasty/stent placement.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
BIOLOGICAL	PVS-10200	PVS-10200 is composed of allogeneic human aortic endothelial cells cultured in a gelatin matrix.

Timeline

• Start date: 2010-04-30
• Primary completion: 2012-06-30
• Completion: 2012-10-31
• First posted: 2010-04-06
• Last updated: 2021-06-28
• Results posted: 2014-02-04

Locations

3 sites across 1 country: France