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Peripheral Arterial Disease clinical trials

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NCT ID: NCT01804439 Completed - Heart Failure Clinical Trials

Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes

Start date: January 1997
Phase: N/A
Study type: Observational [Patient Registry]

Cardiovascular disease (CVD) is an important public health problem that affects millions of people worldwide. Associations between risk factors, such as smoking, dyslipidaemia or hypertension, and prevalent CVD are well documented. However, few studies have investigated associations with onset of disease. The initial manifestation of CVD, for example an episode of unstable angina, is important because it influences the prognosis, the quality of life and the management of disease. Furthermore, the extent to which social deprivation, alcohol consumption or atrial fibrillation affects presentation of CVD is poorly understood and deserves further consideration. Most previous studies have considered CVD as a single entity. However, differences in aetiology between coronary phenotypes suggest that risk factors may not be shared across specific coronary phenotypes and their relative importance is likely to differ for each phenotype. Gaining knowledge of these differences could provide insights into the pathophysiology of specific forms of CVD and could eventually lead to modification of recommendations for patient management and disease prevention. We propose to use the linkage of the national registry of coronary events to general practice records in the Clinical Practice Research Database (CPRD), to investigate whether demographic, behavioral, and clinico-metabolic risk factors differentially influence the onset of specific types of CVD.

NCT ID: NCT01802775 Completed - Clinical trials for Peripheral Arterial Disease

Edoxaban in Peripheral Arterial Disease

ePAD
Start date: February 6, 2013
Phase: Phase 2
Study type: Interventional

This study is a randomized, open-label, blinded endpoint, parallel-group, active-control, multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD), designed to assess the safety and potential efficacy of adding edoxaban to aspirin following femoropopliteal endovascular intervention, with or without stent placement, relative to current treatment practice with clopidogrel and aspirin.

NCT ID: NCT01799811 Completed - Clinical trials for Peripheral Arterial Disease

Cryopreserved Saphenous Vein Allograft in Patients With Critical Limb Ischemia for Peripheral Revascularization

LIMBSAVE
Start date: February 2013
Phase: N/A
Study type: Observational

The objective Study is to evaluate the short- and long-term clinical outcomes of patients receiving the CryoVein cryopreserved saphenous vein allograft (CVA) as their primary open bypass conduit to assess if there is a quantifiable correlation to time of placement as a primary bypass graft and improved long-term clinical outcomes of patients with critical limb ischemia (CLI).

NCT ID: NCT01790243 Completed - Clinical trials for Peripheral Artery Disease

LEVANT 2 Safety Registry

Start date: July 20, 2011
Phase: N/A
Study type: Interventional

The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.

NCT ID: NCT01785693 Completed - Clinical trials for Peripheral Arterial Occlusive Disease

Interest of a Bi-truncal Nerve Block (Femoral + Sciatic) Extended, Systematically Associated With General Anesthesia, in the Femoropopliteal Bypass: Study of Post-operative Analgesia and Peripheral Circulation Downstream

BLOC-FEMPOP
Start date: January 30, 2013
Phase: Phase 4
Study type: Interventional

The aim of this study is to assess, in patients scheduled for femoropopliteal bypass, the benefit of a double peripheral nerve block (femoral + sciatic) with levobupivacaine and clonidine in a single dose, performed before induction of general anaesthesia, on analgesia postoperatively assessed by morphine consumption. Applied to the patient at the beginning of general anesthesia, this technique could allow one hand, to reduce the need for opiates, on the other hand - due to anesthetized limb vasodilation - to improve tissue perfusion downstream.

NCT ID: NCT01785524 Completed - Clinical trials for Peripheral Arterial Disease

Dietary Nitrate and Exercise to Augment Exercise Training Benefits in Subjects With DM+PAD

DM+PAD
Start date: February 2013
Phase: Phase 2
Study type: Interventional

The hypothesis of this proposal is that in subjects with Type II diabetes mellitus (T2D) and peripheral arterial disease (PAD) with intermittent claudication (IC), regular consumption of a high nitrate supplement which raises plasma nitrite, in conjunction with 12 weeks of supervised exercise training at the limb ischemic threshold (SET) will produce a greater clinical benefit (increases in claudication onset time [COT] and peak walking time [PWT] relative to a group with the same exercise training but supplemented with placebo .This study is essentially exploratory in nature and designed to provide us with information to adequately develop power and execute a larger study. We have previously seen benefits from nitrate supplementation on function in PAD.

NCT ID: NCT01784471 Completed - Diabetes Clinical Trials

Open-label Pilot Study to Assess the Use of Magic Footâ„¢ in the Improvment of Parameters in Subject With Foot Symptoms

MF
Start date: November 2012
Phase: N/A
Study type: Interventional

This is a single-arm, single-center, open-label, pilot study . 30 subjects with foot symptoms attributable to diabetes or peripheral vascular disease will be screened . Subjects meeting inclusion criteria will sign informed consent and enrolled. All 30 subjects will be treated with the Magic Footâ„¢. If there is any significant improvement in ICG or foot symptoms as obtained from self evaluation questionnaire, a further 30 subjects will be enrolled.

NCT ID: NCT01783600 Completed - Clinical trials for Peripheral Arterial Disease

NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions

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

The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 12 months) outcome of NanoCrossTM balloon catheter (Covidien) in a prospective, non-randomised, controlled investigation for the treatment of patients with critical limb ischemia (Rutherford 4-5) due to the presence of lesions of minimally 10cm in length at the level of the below-the-knee arteries.

NCT ID: NCT01776710 Completed - Clinical trials for Peripheral Arterial Disease

Structured EDucation for Rehabilitation in Intermittent Claudication

SEDRIC
Start date: April 2013
Phase: N/A
Study type: Interventional

A primary therapeutic goal for patients with intermittent claudication (IC) is to regain lost physical function through exercise rehabilitation. Supervised exercise programmes can markedly improve walking capacity, but these are resource intensive, National Health Service provision is limited, and patients cite accessing services as a barrier to participation. Increasing walking activity via a structured education programme might be a pragmatic solution for improving walking capacity, health and wellbeing in patients with IC; however, further research is needed to substantiate this. Hence, the aim of this project is to develop a pragmatic education programme to increase walking in these patients and to collect data on its feasibility to inform the development of a definitive trial investigating clinical and cost effectiveness. Focus groups will be conducted to inform the development of the education programme. Programme components will be theoretically-underpinned and evidence-based. The development of the programme will be an iterative process involving pilot work, feedback, evaluation, and revision. The programme will then be assessed in a randomised controlled pilot study with 6-week follow-up (n=30). We will assess the feasibility of the intervention and obtain preliminary data of its impact on important outcomes (daily steps/physical activity, walking capacity, quality of life, illness perceptions).

NCT ID: NCT01776424 Completed - Clinical trials for Prevention & Control

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

COMPASS
Start date: February 28, 2013
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are: - To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); - To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.