Advertisement

Topics

Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)

2016-06-27 20:53:21 | BioPortfolio

Summary

The post approval study will enroll US female patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery. Subjects are treated per IFU with the Lutonix Catheter. Subjects will have a Duplex Ultrasound and clinical follow-up through two (2) years.

Description

The Lutonix® 035 Drug Coated Balloon PTA Catheter (Lutonix® Catheter) has been approved by the Food and Drug Administration (P130024) for percutaneous transluminal angioplasty, after pre-dilatation, of de novo or restenotic lesions up to 150mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6mm.The purpose of this trial is to assess the safety and effectiveness of the Lutonix Catheter for treatment of stenosis or occlusion of the femoral and popliteal arteries in the US female population. This study will enroll 160 female patients at a minimum of 10 US centers and a maximum of 25.

Study Design

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

Conditions

Femoral Artery Stenosis

Intervention

Lutonix035 Drug Coated Balloon PTA Catheter

Location

Wellmont CVA Heart Institute
Kingsport
Tennessee
United States
37660

Status

Enrolling by invitation

Source

C. R. Bard

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-27T20:53:21-0400

Clinical Trials [2862 Associated Clinical Trials listed on BioPortfolio]

Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis

Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis can be trea...

Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter

A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech ...

LEVANT 2 Safety Registry

The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral a...

Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries

The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropr...

A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries

To assess the safety and efficacy of the BARD LTX DCB for treatment of stenosis or occlusion of the superficial femoral and popliteal arteries.

PubMed Articles [11637 Associated PubMed Articles listed on BioPortfolio]

Treatment of Very Small De Novo Coronary Artery Disease With 2.0 mm Drug-Coated Balloons Showed 1-Year Clinical Outcome Comparable With 2.0 mm Drug-Eluting Stents.

To evaluate the 1-year clinical outcomes of patients treated with 2.0 mm drug-coated balloon (DCB) vs 2.0 mm drug-eluting stent (DES) implantation in small-caliber vessel de novo coronary artery disea...

Successful management of recurrent iliofemoral venous in-stent stenosis (ISR) with a drug coated balloon (DCB).

Drug-coated vs. Plain Balloon Angioplasty in Bypass Vein Grafts (the DRECOREST I-study).

Stenosis is a known complication in bypass vein grafts for peripheral arterial disease (PAD). The aim of this study was to evaluate the effect of drug-coated balloons (DCB) in the treatment of vein gr...

Endovascular recanalisation with drug coated balloon for chronic symptomatic middle cerebral artery total occlusion.

The optimal treatment for patients with chronic symptomatic middle cerebral artery (MCA) total occlusion is not well established. In addition to medical therapy, vessel recanalisation with stenting ha...

Consequences of an early catheter-based intervention on pulmonary artery growth and right ventricular myocardial function in a pig model of pulmonary artery stenosis.

To determine the consequences of an early catheter-based intervention on pulmonary artery (PA) growth and right ventricular (RV) myocardial function in an animal model of branch PA stenosis.

Medical and Biotech [MESH] Definitions

Placement of a balloon-tipped catheter into the pulmonary artery through the antecubital, subclavian, and sometimes the femoral vein. It is used to measure pulmonary artery pressure and pulmonary artery wedge pressure which reflects left atrial pressure and left ventricular end-diastolic pressure. The catheter is threaded into the right atrium, the balloon is inflated and the catheter follows the blood flow through the tricuspid valve into the right ventricle and out into the pulmonary artery.

Use of a balloon catheter for dilatation of an occluded artery. It is used in treatment of arterial occlusive diseases, including renal artery stenosis and arterial occlusions in the leg. For the specific technique of balloon dilatation in coronary arteries, ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY is available.

Use of a balloon catheter to block the flow of blood through an artery or vein.

Dilation of an occluded coronary artery (or arteries) by means of a balloon catheter to restore myocardial blood supply.

Widening of a stenosed HEART VALVE by the insertion of a balloon CATHETER into the valve and inflation of the balloon.

More From BioPortfolio on "Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Anesthesiology
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Radiology
Radiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...


Searches Linking to this Trial