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Peripheral Arterial Disease clinical trials

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NCT ID: NCT03721939 Recruiting - Clinical trials for Peripheral Arterial Disease

BEnefit of Arterial Preparation by LONGitudinal Scoring

BELONG
Start date: October 24, 2018
Phase: N/A
Study type: Interventional

The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery ("scoring") and therefore promote a regular expansion of atheroma by balloon inflation.

NCT ID: NCT03686306 Recruiting - Clinical trials for Peripheral Artery Disease

VIRTUOSE : Efficiency of Sildenafil on the Absolute Claudication Distance of Peripheral Arterial Disease Patients With Intermittent Claudication.

VIRTUOSE
Start date: November 24, 2021
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 defined as a discomfort and/or pain in the legs during walking. It is the most common clinical feature of PAD. In claudication, primary therapeutic approach is medical treatment and advice to walk. Revascularization is only proposed when medical treatment and advice to walk for at least 3 to 6 months have failed to improve symptoms and walking ability. Optimal medical treatment includes Antiplatelet, Lipid Lowering Drugs, AT2 antagonists / ACE Inhibitors and advice to walk. To date, no other drug has provided consistent evidence for functional improvement in claudication, except for Cilostazol, a type-3 phospho-diesterase inhibitor (PDEi). This compound has been scarcely used in France due to cost and frequent side effect (Headache, Flush, Diarrhea, etc.) and was withdrawn as a therapy in 2010. Sildenafil, a type 5 PDEi, 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. Preliminary data from the literature and unpublished case reports, suggest that this drug could efficiently improve symptoms and walking capacity in patients with stage 2 claudication.

NCT ID: NCT03668821 Recruiting - Clinical trials for Peripheral Artery Disease

Frailty in Vascular Patients Undergoing Surgery

Start date: January 1, 2021
Phase:
Study type: Observational

An observational cohort study of the frailty of vascular surgery patients undergoing intervention and their outcomes.

NCT ID: NCT03668353 Recruiting - Clinical trials for Critical Limb Ischemia

Recombinant SeV-hFGF2/dF Injection for PAOD

Start date: September 5, 2018
Phase: Phase 1
Study type: Interventional

Lower extremity arteriosclerosis obliterans is due to the formation of atherosclerotic plaque in the lower extremities, resulting in the stenosis and occlusion of the artery, leading to chronic ischemia of the limbs. Although bypass surgery and angioplasty ( or interventional therapy ) are effective methods for vascular treatment in patients with PAD to revascularize, a significant proportion of patients with the arterial disease are not eligible for direct arterial surgery. Meanwhile, there are many patients who suffer from diffuse arterial disease or severe peripheral disease not suitable for interventional therapy. Stimulation of arteriogenesis( blood bypassing the occluded arteries through a large number of collateral vessels ) and angiogenesis ( generating new small blood vessels ) have become the focus of research. Our recombinant SeV-hFGF2/dF injection (R&D code BF30 ) uses the human basic fibroblast growth factor ( FGF2 ) gene to express the target protein FGF2 locally by intramuscular injection. The preparation can efficiently express FGF2 in infected cells and secrete it to the periphery and be fixed in the intercellular substance. Since FGF2 is in the upstream regulatory pathway of VEGF, HGF and other factors, it can regulate the coordinated expression of these cytokines related to the growth and function of new blood vessels, and finally, produce mature blood vessels. To evaluate the safety ( tolerance), pharmacokinetics (PK), biological activity, and immunogenicity of BF30 in patients with lower extremity arterial occlusive disease, and to explore clinical benefits. MAIN OBJECTIVE: To evaluate the safety ( tolerability ) of single-dose BF30 in patients with lower extremity arterial occlusive disease, and to provide evidence for the dose of subsequent clinical trials. Secondary objective: To explore the pharmacokinetics (PK), biological activity, the immunogenicity of BF30, and to initially explore clinical benefits.

NCT ID: NCT03663777 Recruiting - Clinical trials for Peripheral Arterial Disease

Handgrip Training in Patients With Peripheral Artery Disease

Isopress_03
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to analyze the effects of isometric handgrip training (IHT) on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 30 patients which will be randomized into 2 groups (15 per group), IHT and control group (CG). IHT group will training isometric contraction for 12 weeks. In CG patients will be encouraged to increase the level of physical activity. In the pre and post-intervention cardiovascular measures will be obtained.

NCT ID: NCT03649204 Recruiting - Clinical trials for Peripheral Arterial Disease

Effect of a Hybrid Rehabilitation Program on Walking, Quality of Life & Cardiovascular Risk in People With PAD

HY-PAD
Start date: July 9, 2019
Phase:
Study type: Observational

Peripheral arterial disease (PAD), a disabling condition, affects 800,000 Canadians. People with PAD suffer from poor quality of life due to leg pain, which makes walking difficult. They also have a high risk of heart disease. In November of 2017, the University of Ottawa Heart Institute (UOHI) launched Canada's first specific walking rehabilitation and cardiovascular risk reduction program dedicated to patients with PAD. An on-site, supervised exercise program to improve walking endurance and quality of life in PAD has been shown to be successful. However many patients are not able to participate in the on-site program due to barriers such as transportation, parking, or other commitments. Recently, a home-based walking program has also been shown to significantly improve walking endurance and quality of life among people with PAD. It was decided that a hybrid program, that has a short on-site program followed by a home-based program may allow more patients to participate and have the highest chance of success. The goal is to develop a new hybrid program for medical care in PAD patients in order to: (a) improve their walking distance, (b) improve their quality of life and (c) improve their cardiovascular risk. As part of this study the investigators will enrol 25 participants with PAD. Participants will be studied at baseline (before their first on-site class) and at 3 month follow up (after their last home program phone call).

NCT ID: NCT03640767 Recruiting - Clinical trials for Message-based Rehabilitation for Peripheral Artery Disease Patients

Effectiveness of Text Message-based Rehabilitation Program for Patients With Peripheral Artery Disease

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Background: Many patients with peripheral artery disease are unable to achieve healthy lifestyle after revascularization. There is evidence that rehabilitation program could result in decreased re-admission, reduced cardiometabolic risk factors and improved quality of life. Aim: This first randomized controlled trial to examine the effectiveness of mobile phone text message-based rehabilitation on low density lipoprotein (LDL), Ankle Brachial Index (ABI), healthy lifestyle behaviors and quality of life for patients after revascularization. Methods: This is a 6 months randomized controlled trial. It is hypothesized that message-based rehabilitation program will be effective in improving the low density lipoprotein (LDL), Ankle Brachial Index (ABI), healthy lifestyle behaviors and quality of life for patients with peripheral artery disease after surgical revascularization. A total of 160 participants will be recruited for the study. The participants will be randomly divided into intervention and control groups. Both intervention and control groups will receive face-to-face lifestyle adherence counseling and booklet at baseline. The intervention group will receive 4 mobile phone messages per week for 24 weeks. All participants will be asked to fill in the questionnaires at the baseline, 6-week and 6-month follow-up in Surgical Out Patient Department (SOPD). Participants' blood results of low density lipoprotein (LDL) at the baseline and at 6-month follow-up will be retrieved from Computer Management System in SOPD The primary outcomes are the fasting LDL levels at 6 months. Secondary outcome are Ankle-Brachial Index (ABI), BMI, Fasting glucose level, HDL level, Total cholesterol level, self-reported adherence to healthy lifestyle behaviours, quality of life and smoking status. Participants: The target participants of this study are peripheral artery disease patients who have received revascularization in the Surgical Department of a regional hospital in Hong Kong. The eligible participants are Chinese, aged 50 years or above, and with medical record of peripheral artery disease with revascularization done in the past 6 months. The participants should be able to receive and read Chinese texts from their own mobile phones and are available to come back for a 6-month follow-up for lifestyle counselling. The potential participants will be excluded if they refuse to provide an informed-consent form or if they have medical records stating their lack of capacity to provide informed consent. The recruitment procedure will take place in Department of Surgery in a regional hospital. Study setting: The study will be conducted in the Surgical Department of a regional hospital in Hong Kong.

NCT ID: NCT03638115 Recruiting - Clinical trials for Peripheral Artery Disease

The VaSecure BTK Study

Start date: October 30, 2018
Phase: N/A
Study type: Interventional

To assess the safety and performance of the VaSecure drug-coated PTA balloon catheter in the treatment of patients with Chronic Limb Threatening Ischemia (CLTI) of the lower limb below the knee (BTK)

NCT ID: NCT03622359 Recruiting - Diabetes Mellitus Clinical Trials

Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

Start date: February 17, 2017
Phase: N/A
Study type: Interventional

The aim of this clinical study is to 1) establish a healthy database for nuclear perfusion imaging of the lower extremities and 2) assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in patients with peripheral artery disease (PAD) who are undergoing lower extremity revascularization procedures. We hypothesize that radiotracer imaging of the lower extremities will provide a sensitive non-invasive imaging tool for quantifying regional abnormalities in skeletal muscle perfusion and evaluating responses to medical treatment.

NCT ID: NCT03528811 Recruiting - Clinical trials for Peripheral Vascular Disease in Diabetes

Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

Start date: August 1, 2016
Phase: Phase 1
Study type: Interventional

The main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.