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Intermittent Claudication clinical trials

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NCT ID: NCT01731990 Terminated - Clinical trials for Peripheral Artery Disease

Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease

Start date: October 30, 2012
Phase: Phase 2
Study type: Interventional

This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg artery structure and physical activity in patients with atherosclerotic peripheral artery disease and leg pain from walking.

NCT ID: NCT01727752 Active, not recruiting - Clinical trials for Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis

A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis

FELIX
Start date: October 2007
Phase: N/A
Study type: Interventional

A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis

NCT ID: NCT01679990 Completed - Clinical trials for Peripheral Artery Disease

Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)

Start date: November 5, 2012
Phase: Phase 2
Study type: Interventional

The objective of the study is to establish the safety profile of Intramuscular PLX-PAD injections and to evaluate the clinical efficacy of it in IC subjects comprising of 4 treatment groups: 1. Double treatment of PLX-PAD low dose 2. Double treatment of PLX-PAD high dose 3. Double treatment of Placebo 4. Single treatment of PLX-PAD high dose and additional treatment of Placebo. Subjects will receive the assigned treatment twice to the affected leg, within 12-weeks interval between each treatment. The study will be comprised of 5 stages: Screening period of up to 4 weeks,first treatment of PLX-PAD or placebo followed by additional injection after 12 weeks and with follow-up of 12 months post second injection

NCT ID: NCT01602159 Completed - Claudication Clinical Trials

Revascularization With Open Bypass Versus Angioplasty and STenting of the Lower Extremity Trial (ROBUST)

ROBUST
Start date: July 2009
Phase: N/A
Study type: Interventional

This is a prospective randomized controlled trial to compare clinical improvement, cost effectiveness and patency rates between new and improved Nitinol stents and open bypass surgery in the superficial femoral artery disease. Secondary outcomes also include comparing quality of life, re-intervention rate, mortality, morbidity and time to return to work or regular activities. Patients with superficial femoral artery lesions will be considered. Patients with TASC II A lesions will not be randomized but treated with PTA/stenting as standard of care. Patients with TASC II B and C lesions will be prospectively randomized into either receiving open bypass or stenting. Patients with TASC D lesions will be treated with open bypass surgery after angiography. The investigators will collect pre-procedure, peri-procedural and clinical follow-up data on all enrolled the patients.

NCT ID: NCT01484509 Completed - Clinical trials for Intermittent Claudication

Subjective and Objective Methods of Assessing Walking Limitation Due to Claudication

Start date: June 2011
Phase: N/A
Study type: Observational

Leg artery disease is a common condition in which fatty deposits develop in the blood vessels that supply the legs. Many patients with leg artery disease experience a cramp-like leg pain during walking that is relieved by rest; this is called intermittent claudication. To help determine the severity of leg artery disease, patients may be questioned about how far they can walk before claudication pain forces them to stop. However, this information is usually of limited use because most patients poorly estimate their walking capacity. The investigators have developed a simple questionnaire to help estimate walking capacity in patients with leg artery disease. The purpose of this study is to test the validity and reliability of this questionnaire. By validity, the investigators mean the extent to which the questionnaire measures what it is supposed to measure (walking capacity). By reliability, the investigators mean the extent to which the questionnaire produces the same results over time when completed on two different days. The investigators hypothesise that the investigators simple questionnaire will be valid and reliable.

NCT ID: NCT01468974 Completed - Atherosclerosis Clinical Trials

ESPRIT I: A Clinical Evaluation of the Abbott Vascular ESPRIT BVS (Bioresorbable Vascular Scaffold) System

Start date: November 2011
Phase: N/A
Study type: Interventional

The purpose of the ESPRIT I Clinical Investigation is to evaluate the safety and performance of the ESPRIT BVS in subjects with symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries.

NCT ID: NCT01450722 Recruiting - Claudication Clinical Trials

Paclitaxel Eluting Stent in Long SFA Obstruction: A Prospective, Randomized Comparison With Bypass Surgery

finnptx
Start date: October 2011
Phase: Phase 3
Study type: Interventional

Chronic lower limb ischemia due to atherosclerosis causes significant morbidity especially in elderly: the prevalence of asymptomatic obstructive peripheral atherosclerosis among 40-74 old is 4-22%. The prevalence of its milder symptomatic manifestation, intermittent claudication among 40 years old men is about 1% and among 70 years old it is 7%. In about 10% of the patients the ischemia worsens to threat the vitality of the limb. Although intermittent claudication has a benign prognosis and can often treated conservatively, more severe forms with extensive arterial obstructions require revascularization, either open surgical or endovascular. Surgical bypass operations are currently the standard reference for treating long femoral artery obstructions. Surgical bypass operations are accompanied by significant acute complications and late adverse effects, especially in patients with associated cardio-cerebrovascular and pulmonary diseases, and less invasive, safe, and effective endovascular therapies are seeked for. The long term patency rates of infrainguinal balloon angioplasty (PTA) vary largely in different studies but they are mostly poor when long femoral arterial obstructions have been treated. Drug eluting stents have shown great promise in coronary artery interventions. The purpose of this study is to compare Paclitaxel eluting Zilver PTX nitinol stent (Cook INC) with bypass surgery using PTFE graft to proximal popliteal artery in the treatment of long femoral artery obstructions (total length of 10-25 cm) in a prospective, randomized, Finnish multi center trial with consecutive claudicant and chronic critical ischemia patients. The aim is to randomize altogether 400 patients during about two years in five universities and in 2-3 central hospitals. The primary end point is patency at 24 month follow up. Secondary end points are primary success at patient discharge, complications, 30-day mortality, target lesion revascularization, quality of life, and economical analysis.

NCT ID: NCT01420289 Completed - PVD Clinical Trials

Effect of HPIPC for the Treatment of Ischemic Ulcers in Subjects With PAD

Start date: January 2009
Phase: N/A
Study type: Interventional

To evaluate the effects of HPIPC for the treatment of symptoms of PAD

NCT ID: NCT01385774 Terminated - Clinical trials for Peripheral Arterial Disease

SUPER Study; SUPERvised Exercise or Angioplasty for Intermittent Claudication Due to an Iliac Artery Obstruction.

SUPER
Start date: November 2010
Phase: N/A
Study type: Interventional

The purpose of our study is to compare the clinical effectiveness and cost-effectiveness of two treatment strategies of Intermittent Claudication (IC) due to an iliac artery obstruction: to start with SUPERvised Exercise Therapy (SET) and deferred Percutaneous Transluminal Angioplasty (PTA) in case of SET failure, or immediate PTA. It is our hypothesis that PTA as first line treatment is more effective than SET as first line treatment with regard to maximum walking distance, quality of life and costs after one year.

NCT ID: NCT01366482 Completed - Clinical trials for Peripheral Arterial Disease

Atherectomy Followed by a Drug Coated Balloon to Treat Peripheral Arterial Disease

DEFINITIVE AR
Start date: July 2011
Phase: N/A
Study type: Interventional

The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease.