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Intermittent Claudication clinical trials

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NCT ID: NCT03204825 Completed - Clinical trials for Peripheral Arterial Disease

Pain Management and Patient Education for Physical Activity in Intermittent Claudication (PrEPAID)

PrEPAID
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

Peripheral Arterial disease is a common condition which causes narrowing of the arteries. The most common symptom that patients with PAD experience is Intermittent Claudication (IC), pain in the lower limb(s) on exertion, which is relieved by rest. IC reduces patients' quality of life (QoL) by limiting their ability to walk and engage in daily activities. Regular exercise and physical activity (PA) are central to the management of PAD and help to improve walking distances and reduce the risks associated with PAD such as heart attack and stroke. However, exercise and PA in this population is often limited due to pain. Investigators have shown that Transcutaneous Electrical Nerve Stimulation (TENS) can help to reduce pain and increase walking distance in patients with PAD. Investigators have also shown that educating patients about their condition and helping them to set goals has the potential to increase PA, and quality of life. This study will examine the feasibility of designing a definitive trial that investigates whether TENS can improve the physical activity of patients with PAD when delivered alone and/or alongside a patient education programme.

NCT ID: NCT03203239 Recruiting - Clinical trials for Peripheral Artery Disease

Red Light Treatment in Peripheral Artery Disease

Start date: January 17, 2018
Phase: N/A
Study type: Interventional

Subjects with a known diagnosis of peripheral artery disease as measured by an abnormal ankle brachial index (<.9 or >1.1) will undergo a single 5 min exposure of 670 nm light, 1 cm above the gastrocnemius muscle. Blood flow will be measured by infusion of ultrasound contrast and subsequent acquisition of ultrasound images. 2 blood samples will be collected for measurement of nitric oxide metabolites.

NCT ID: NCT03194776 Completed - Clinical trials for Peripheral Artery Disease (PAD); Intermittent Claudication

Study of LLG783 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication

PAD PoC
Start date: September 20, 2017
Phase: Phase 2
Study type: Interventional

This study is designed to determine whether LLG783 displays the clinical safety and efficacy profile, after multiple i.v. doses, to support further development in patients with PAD and intermittent claudication.

NCT ID: NCT03071146 Completed - Clinical trials for Peripheral Arterial Disease

Utility, Safety, and Effectiveness of the Bard LifeStent 5F Vascular Stent System

REALITY III
Start date: February 15, 2017
Phase:
Study type: Observational

The medical device being examined in this study is the Bard® LifeStent® 5F Vascular Stent System. It is intended for use in patients who suffer from peripheral artery disease (PAD). PAD is generally associated with blocked arteries of the legs. The superficial femoral artery (SFA) and popliteal artery are common locations for this problem to develop. The patient may experience pain or discomfort in the leg that occurs when walking or have other complications associated with wound healing. The purpose of this study is to collect information to assess the deliverability, clinical utility, safety and effectiveness of the Bard® LifeStent® 5F Vascular Stent System.

NCT ID: NCT03048955 Withdrawn - Clinical trials for Spinal Stenosis, Lumbar Region With Neurogenic Claudication

Assessing Superion Clinical Endpoints vs. Decompression

ASCEND
Start date: February 8, 2017
Phase: N/A
Study type: Interventional

PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical Success of the study group receiving the Superion® IDS is not inferior to the success rate observed in the study group treated by direct decompression at 60 months follow-up. Secondarily, the trial is intended to establish that Composite Clinical Success of the study group receiving the Superion® IDS at 24 months is not inferior to the success rate observed at 24 months in patients treated with the Superion® IDS in the original IDE trial. Thirdly, the trial is intended to establish that Composite Clinical Success of the population receiving the Superion® IDS in this trial at 24 months is not inferior to the success rate observed at 24 months in patients treated with direct decompression.

NCT ID: NCT03048890 Recruiting - Clinical trials for Peripheral Artery Disease

VascTrac Peripheral Arterial Disease (PAD) Study

VascTrac
Start date: March 1, 2017
Phase:
Study type: Observational

VascTrac is a mobile medical application that tracks users' physical activity levels in order to predict endovascular failure of patients with Peripheral Artery Disease.

NCT ID: NCT02993874 Recruiting - Clinical trials for Intermittent Claudication

Creatine Supplementation in Patients With Intermittent Claudication.

Start date: June 26, 2017
Phase: N/A
Study type: Interventional

The aim of this study will be to verify the effect of creatine supplementation associated to clinical treatment of the functional capacity in patients with intermittent claudication.

NCT ID: NCT02930811 Withdrawn - Clinical trials for Peripheral Arterial Occlusive Disease

Efficacy of Sildenafil on the Morbi-mortality of Peripheral Arterial Diseased Patients With Intermittent Claudication

VALSTAR
Start date: n/a
Phase: Phase 3
Study type: Interventional

Peripheral Arterial Disease (PAD) is a highly debilitating disease that affects 202 million people around the world and about 7 million people in France. Morbi-mortality from cardiovascular events is increased in this population. Intermittent claudication is the most common clinical feature of PAD. Primary therapeutic approach is medical treatment and advice to walk. Sildenafil, a PDEi type 5, is well tolerated, largely used in impotence and has interesting clinical delay and duration of action in the concept of a potential use in claudication. For patients agreeing and signing informed consent, randomisation of treatment (placebo/sildenafil) will be done. Treatment will be proposed in addition to usual treatment. The experimental drug will be delivered for a 1 month treatment. First follow up visit at month one will focus on tolerance, compliance and eventual side effects. If no major side effect is found the study drug will then be delivered for an additional 2 months. Patients will be evaluated at month 3 (second follow-up visit) for persistent or non-persistent indication for revascularisation and addressed for revascularization if needed. In parallel focus on tolerance, compliance and eventual side effects will be done. If no major side effect is found, the study drug will be delivered for an additional 3 months treatment. Third and fourth follow-up visit are scheduled at month 6 (end of treatment) and month 9 (3 months after the end of experimental drugs).

NCT ID: NCT02927574 Completed - Clinical trials for Peripheral Arterial Disease

Systematic Review and Meta-Analysis on DCB vs. POBA in De-novo Femoropopliteal Disease

DOND
Start date: July 2016
Phase:
Study type: Observational [Patient Registry]

Restenosis is still an issue after endovascular revascularization for femoropopliteal occlusive disease. One approach to reduce the rates of restenosis and reintervention is local application of Paclitaxel with drug-coated balloon angioplasty. The purpose is to conduct a systematic review and meta-analysis of randomized-controlled trials comparing on Drug-Coated Balloon angioplasty (DCB) vs. Plain Old Balloon Angioplasty (POBA) in de-novo femoropopliteal disease.

NCT ID: NCT02924857 Active, not recruiting - Ischemia Clinical Trials

The Chocolate Touch Study

Start date: July 26, 2017
Phase: N/A
Study type: Interventional

The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study, designed to show sufficient safety and effectiveness of the Chocolate Touchâ„¢ for use in superficial femoral or popliteal arteries with the intention of obtaining regulatory approval to market this device in the United States