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

2014-08-27 03:14:45 | BioPortfolio


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).


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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Peripheral Artery Disease




Centre Hospitalier Universitaire d'Amiens




Pervasis Therapeutics, Inc

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:14:45-0400

Clinical Trials [1836 Associated Clinical Trials listed on BioPortfolio]

Genetics of Peripheral Artery Genomics

Peripheral artery disease is a disease that contributes to significant morbidity and mortality of millions of Americans yearly. Very little is known about the pathophysiology of atheroscl...

Comparison of 2 Beta Blocker Drugs on Peripheral Arterial Disease in Patients With High Blood Pressure

This is a 26-week, prospective double-blind, randomized pilot trial of nebivolol versus an active control, metoprolol succinate, in patients with established lower-extremity peripheral art...

Exercise in Peripheral Artery Disease

This research project aims to investigate the gender-based difference in patients with peripheral artery disease. To attend this, this study has two specific objectives: Objective 1: To i...

Community Walking Enhanced by Orthoses for Patients With Peripheral Artery Disease

The primary aim of this study is to investigate the effect of an ankle foot orthoses (AFO) on the primary outcome of peak walking time (PWT) in patients with peripheral artery disease (PAD...

Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease

To compare two different Paclitaxel coated balloons in the treatment of high grade stenotic or occluded lesions in Superficial femoropopliteal artery (SFA )and/or Proximal Popliteal Artery...

PubMed Articles [18147 Associated PubMed Articles listed on BioPortfolio]

Transpedal Access for the Management of Complex Peripheral Artery Disease.

To evaluate the safety and efficacy of transpedal access for the management of complex peripheral artery disease (PAD).

Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.

The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because ...

Association between 1p13 polymorphisms and peripheral arterial disease in a Chinese population with diabetes.

Variants on chromosome 1p13 have been associated with coronary artery disease and acute myocardial infarction risk in different ethnics. This study was aimed to investigate the association between 1p1...

Prevalence of peripheral artery disease (PAD) and factors associated: An epidemiological analysis from the population-based Screening PRE-diabetes and type 2 DIAbetes (SPREDIA-2) study.

To describe the prevalence of Peripheral Artery Disease (PAD) in a random population sample and to evaluate its relationship with Mediterranean diet and with other potential cardiovascular risk factor...

Socioeconomic Status and Incidence of Hospitalization With Lower-Extremity Peripheral Artery Disease: Atherosclerosis Risk in Communities Study.

Compared to coronary heart disease, heart failure, and stroke, the relationship between low socioeconomic status (SES) and peripheral artery disease (PAD) is less well established. We examined the ass...

Medical and Biotech [MESH] Definitions


Surgical therapy of ischemic coronary artery disease achieved by grafting a section of saphenous vein, internal mammary artery, or other substitute between the aorta and the obstructed coronary artery distal to the obstructive lesion.

Insertion of a catheter into a peripheral artery, vein, or airway for diagnostic or therapeutic purposes.

Direct myocardial revascularization in which the internal mammary artery is anastomosed to the right coronary artery, circumflex artery, or anterior descending coronary artery. The internal mammary artery is the most frequent choice, especially for a single graft, for coronary artery bypass surgery.

Abdominal artery that follows the curvature of the stomach. The right gastroepiploic artery is frequently used in CORONARY ARTERY BYPASS GRAFTING; MYOCARDIAL REVASCULARIZATION, and other vascular reconstruction.

More From BioPortfolio on "Study of PVS-10200 for the Treatment of Restenosis in Patients With Peripheral Artery Disease (TRIUMPH)"

Quick Search


Relevant Topic

A stent is a small mesh tube that's used to treat narrow or weak arteries. Arteries are blood vessels that carry blood away from your heart to other parts of your body.  A stent is placed in an artery as part of a procedure called angioplasty. &...

Searches Linking to this Trial