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Peripheral Artery Disease clinical trials

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NCT ID: NCT01969630 Recruiting - Clinical trials for Peripheral Artery Disease

Paclitaxel-eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-eluting Stent for the Treatment of Femoropopliteal de Novo Lesions

Start date: October 2013
Phase: Phase 4
Study type: Interventional

To determine in patients with symptomatic femoropopliteal lesions whether percutaneous revascularization with paclitaxel-eluting balloon angioplasty (PEB) and provisional nitinol stent is superior with respect to the 12-month incidence of restenosis compared to treatment with systematic paclitaxel-eluting stent (PES) angioplasty

NCT ID: NCT01960647 Recruiting - Clinical trials for Peripheral Artery Disease

FREERIDE STUDY, Freeway Paclitaxel Coated Balloon Catheter to Treat Peripheral Artery Disease

Start date: May 2011
Phase: Phase 3
Study type: Interventional

The primary objective of this prospective, Randomized, Controlled, Multicentre, Open Study is to investigate the inhibition of restenosis by the Paclitaxel-eluting Percutaneous transluminal angioplasty (PTA) balloon Freeway versus PTA alone in the treatment of de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal arteries.

NCT ID: NCT01941030 Completed - Clinical trials for Peripheral Artery Disease

Complete Lesion Assessment With ffR and IVUS TechnologY

CLARITY I
Start date: March 2013
Phase: N/A
Study type: Interventional

CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).

NCT ID: NCT01938391 Completed - Clinical trials for Peripheral Artery Disease

Tissue Removal Assessment With Ultrasound of THe SFA and Popliteal

TRUTH
Start date: January 2013
Phase: N/A
Study type: Interventional

IVUS imaging will be utilized to assess performance of the Sponsor's Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) in patients who have symptomatic peripheral artery disease (PAD) occurring in the Superficial Femoral Artery (SFA), Popliteal (POP), and/or Tibioperoneal Trunk (TPT).

NCT ID: NCT01920308 Completed - Clinical trials for Peripheral Artery Disease

A Prospective Study of the Performance of the Bard® LifeStent® Vascular Stent Systems (REALITY)

REALITY
Start date: August 2013
Phase: N/A
Study type: Observational

The purpose of this study is to assess the deliverability, clinical utility and effectiveness of the 5 mm diameter size offering of the LifeStent® Vascular Stent

NCT ID: NCT01912937 Completed - Clinical trials for Peripheral Artery Disease

Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:

PK
Start date: June 2013
Phase: Phase 2/Phase 3
Study type: Interventional

To describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or restenotic lesion(s), occluded/stenotic or re-occluded/restenotic lesion(s).

NCT ID: NCT01901224 Terminated - Clinical trials for Peripheral Artery Disease

Metformin, Muscle Energetics, and Vascular Function in Older Adults With Peripheral Artery Disease

Start date: July 2013
Phase: Phase 4
Study type: Interventional

The investigators are doing this research study to find out if taking Metformin improves walking ability in patients with peripheral arterial disease (PAD). In PAD the arteries (blood vessels) in the legs are narrowed because of the build up of plaque. The leg muscle can hurt in patients with PAD and this is usually described as a cramp or tiredness. This pain is called intermittent claudication. Metformin is an FDA approved medication for the treatment of diabetes. The investigators believe that Metformin may help your leg muscles work better. The investigators will enroll up to 100 subjects in order to find 60 subjects with PAD at Brigham and Women's Hospital (BWH).

NCT ID: NCT01897103 Completed - Clinical trials for Peripheral Artery Disease

Platelet Activity in Vascular Surgery for Thrombosis and Bleeding

PIVOTAL
Start date: June 2013
Phase: N/A
Study type: Observational

The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers during the perioperative period. The goal is to develop a clinically useful assessment of platelet/coagulation activity for risk stratification that may ultimately serve as a target for therapeutic intervention. This study will enroll 200 patients with peripheral artery disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is scheduled to begin enrollment in July 2013 for approximately two years.

NCT ID: NCT01895725 Active, not recruiting - Clinical trials for Coronary Artery Disease

Correlation of Artherosclerotic Plaque Volume and Intima Media Thickness With Soluble P-selectin

Start date: June 2013
Phase:
Study type: Observational

The proposed project is a prospective observational, single-center cohort study aimed to examine the progression of atherosclerotic alterations of the carotid arteries (IMT, plaque volume) during a follow-up of up to four years and to correlate the observed changes with traditional and novel biomarkers of atherosclerosis. A total of 600 subsequent patients with or established cardiovascular disease or at least one cardiovascular risk will be tested with a high-frequency ultrasound probe equipped with automated IMT measurements and 3D quantitative plaque volumetry. Plasma samples will be collected and tested for traditional and novel cardiovascular risk factors. Both ultrasound examinations and blood sampling will be repeated once per year to assess changes in these parameters over time depending on treatment modalities, which are left to the discretion of the treating physicians. The primary endpoint of the planned study will be the correlation between P-selectin and the progression of atherosclerosis as measured by plaque volume and IMT in the carotid and femoral arteries, respectively. Secondary endpoints will include the correlation of established (hypertension, smoking, diabetes, dyslipidemia) and novel risk factors (hsCRP, P-selectin, cholesteryl ester transfer protein (CETP), intercellular adhesion molecule-1 (ICAM-1), CETP TaqIb polymorphism) with the progression of atherosclerosis, the correlation of cardiovascular events with the progression of atherosclerosis and the additional predictive value of plaque volume and IMT compared to an established risk score (SCORE card).

NCT ID: NCT01867736 Completed - Atherosclerosis Clinical Trials

BIOLUX P-II First-in-Man Study to Compare the Passeo-18 Lux DRB Against POBA in Infrapopliteal Arteries

BIOLUX P-II
Start date: July 2012
Phase: N/A
Study type: Interventional

A prospective, multicentric, randomized controlled trial to assess the safety and performance of the Passeo-18 Lux Paclitaxel releasing PTA balloon catheter versus the uncoated Passeo 18 PTA balloon catheter for the treatment of stenosis, restenosis or occlusion of the infrapopliteal arteries.