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Peripheral Artery Disease clinical trials

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NCT ID: NCT03743636 Completed - Clinical trials for Peripheral Artery Disease

Nicotinamide Riboside With and Without Resveratrol to Improve Functioning in Peripheral Artery Disease

NICE
Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

NICE is a randomized clinical trial that will examine the effects of nicotinamide riboside (NR) both with and without resveratrol to test whether, among people with PAD, NR significantly improves walking performance more than placebo and whether NR combined with resveratrol significantly improves walking performance more than placebo. If findings support the hypotheses, results will be used to design a large, definitive randomized clinical. The study will randomize 90 participants with PAD to one of the following three groups: NR + resveratrol, NR + placebo, or placebo + placebo.

NCT ID: NCT03734549 Recruiting - Clinical trials for Peripheral Artery Disease

Predicting Procedural and Long-term Outcomes of Endovascular Revascularization for Lower Extremity Peripheral Artery Chronic Total Occlusions With Computed Tomographic Angiography

Start date: December 1, 2017
Phase:
Study type: Observational

Nearly one-half of all lower extremity percutaneous interventions performed in patients with symptomatic peripheral artery disease (PAD) involve chronic total occlusions (CTOs) which are technically more challenging and are associated with more periprocedural complications and lower rates of procedural success comparing with non CTOs. Despite innovate dedicated CTO devices developed and provides higher technical success, a wire-catheter approach to cross peripheral artery CTO is most often the first choice of operators as its lower cost advantage.Subhash Banerjee MD reported of all 1,362 CTOs, wire-catheter approaches were used in 82% and the technical success rate was 65%. If the operators chose wire-catheter as primary crossing device at the beginning of the procedure, but the technically failed with the provisional use of re-entry or crossing devices to try to procedural success. Such procedures add incrementally to procedure duration and cost and the revascularization and amputation rate at 12 month were highly increased comparing with using dedicated CTO devices initially. So it is very important to predict the outcome of guidewire crossing through CTOs to direct the choice of crossing strategy. Current data suggested that computed tomography angiography (CTA) imaging of PAD and a detailed comprehensive assessment for CTO arteries before endovascular therapy can assist preprocedural planning to maximize procedural success. Previous studies about coronary CTOs prediction scores as the KCCT score and CT-based CT-RECTOR provide the factors including occlusion length, the shape of proximal entry site, severe calcification, and etc. characters base on CTA correlating with the outcome of cross. As the same physiopathologic mechanism, we hypothesized that the radiographic characteristics are connected with outcomes of guidewire crossing occlusions. To our knowledge, few studies focused on how to predict the successful GC through peripheral artery CTO, therefore, the purpose of this study was to establish a simple and clinically applicable prediction model based on CTA characters within the occlusive lesions and clinical parameters to predict the GC outcomes of patients with lower extremity CTO. In addition, the long-term effect of endovascular revascularization are very important. An analysis concluded that limb adverse event (repeat revascularization rate 17.2%, amputation rates 8.5%) at 12-month in the CTOs with direct wire-catheter crossing strategy. Base on the proven influence factors (the lesion length, small diameter of the vessel and severe calcification, mechanical exposure, etc.)of adverse event at after endovascular revascularization ,we also can establish model with preoperative computer tomography angiography that provided the lesion detail characteristic combing the patients' biochemical and clinical feature to predict the adverse event rate at 12-month after endovascular revascularization.

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: NCT03676842 Terminated - Clinical trials for Peripheral Artery Disease

Prospective Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and/or Popliteal Arteries Using the FLEX Scoring Catheter Plus DCB

FORTEZ
Start date: October 11, 2018
Phase: N/A
Study type: Interventional

Prospective, single-center, single-arm, non-randomized study to assess the safety and efficacy of the FLEX Scoring Catheter in patients with atherosclerotic peripheral artery disease in the superficial femoral and popliteal arteries.

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: 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: NCT03554564 Completed - Clinical trials for Peripheral Artery Disease

Project VOICE: Vascular Outcomes Improvement Through Collection of PatiEnt Reported Data

VOICE
Start date: August 2, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the feasibility of a digital health platform coupled with walking activity tracking for patients with Peripheral Artery Disease (PAD) and symptoms limited to claudication.

NCT ID: NCT03547817 Completed - Clinical trials for Peripheral Artery Disease

Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Optimal Pulse Pressure Regime

Start date: May 15, 2018
Phase: N/A
Study type: Interventional

Recent studies have shown that applying intermittent negative pressure (INP) with short negative pressure (-40 mmHg) pulses to the lower extremities increase arterial blood flow velocity and skin blood flow. However, the optimal magnitude of negative pressure to improve blood flow is not known, and needs further investigation. Peripheral arterial blood flow velocity, skin blood flow and skin temperature in the foot will be recorded at different levels of oscillating negative pressure to identify a pressure range which is practically, while at the same time induce clinically relevant changes in blood flow parameters. Heart rate and blood pressure will be recorded to monitor the effects on the central circulation.

NCT ID: NCT03524963 Completed - Clinical trials for Peripheral Artery Disease

Comparative Pharmacokinetic Study Between Two Extended-Release Cilostazol Formulations in Korea

Start date: August 7, 2017
Phase: Phase 1
Study type: Interventional

This is a randomized, open-label, multiple-dose, two-sequence, two-period crossover study to to compare the safety/tolerability and pharmacokinetics between Pletaal SR Cap. and Cilostan CR Tab. in healthy volunteers