300,000+ clinical trials. Find the right one.

154 active trials for Peripheral Arterial Disease

European All-comers' Multicentric Prospective REGISTRY on LUMINOR© Drug Eluting Balloon in the Superficial Femoral Artery and Popliteal Artery With 5 Years Follow-up.

The objective of this all-comers registry is to explore the safety, efficacy, and cost-efficiency of the LUMINOR© DEB in de-novo and restenotic-FP lesions. For de-novo and restenotic lesions, especially for calcified and/or long lesions/occlusions, the use of debulking devices to improve recalibration and drug penetration will be evaluated in a specific sub-group.

Start: January 2021

Tissue Monitoring During Endovascular Intervention

Tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions. In practice though, tissue perfusion measurements are not routinely undertaken as few practical solutions exist that are easy to use and fit in everyday clinical practice. Pedra has developed a novel, easy to use, non-invasive device that can be used in practice to better inform treatment decisions.

Start: March 2021

Stellarex Vascular E-Registry

Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.

Start: June 2016

Measuring the ACT During Non-cardiac Arterial Procedures.

Aim of the MANCO study is to establish for once and for all that monitoring the effect of heparin during NCVI (Non-Cardiac Vascular Interventions) is essential to ensure the individual patient of safe and tailor-made anticoagulation. Not measuring the effect of the administered heparin exposes the patient to unnecessary risks of thrombo-embolic and bleeding complications. First aim of the MANCO study is to prove that the standardized bolus of 5000 IU of heparin, used by 90% of vascular specialists in Europe, results in inadequate anticoagulation in more than 80% of patients. These measurements will be performed using the Hemostasis Management System by Medtronic.

Start: December 2016

Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement

I. To investigate whether patient characteristics, exercise therapy characteristics, local metabolic exercise response, endothelial function, autonomic function or atherosclerotic lesion location can predict the walking response to a successfully completed semi-supervised exercise intervention in patients with intermittent claudication (WP I) II. To assess the effect of a home-based exercise intervention with remote monitoring and coaching on cardiovascular risk factors in patients with intermittent claudication (WP II)

Start: March 2019

Exercise and Weight Loss in PAD

This study is designed to examine the added benefits of weight loss to an exercise program in older obese Veterans with peripheral arterial disease. The investigators want to determine if weight loss in addition to exercise will 1) improve walking ability to a greater extent than exercise alone and 2) determine the underlying reasons why walking ability improves by measuring blood flow and the amount of muscle in the leg muscles.

Start: October 2015

Effects of Esmolol Infusion on Hemodynamic Responses to Isometric Handgrip

This study will test the hypothesis that Esmolol hydrochloride, a beta-1 selective blocker, improves myocardial oxygen (O2) supply-demand balance at rest and during isometric (handgrip) stress in adults with peripheral artery disease (PAD) and healthy controls.

Start: May 2021

Effect of Beetroot Juice on Coronary Blood Flow and Walking Performance in PAD

In this study the investigators will test the hypothesis that short-term consumption of inorganic nitrate (supplied in concentrated beetroot juice) enhances coronary blood flow responses, large artery hemodynamics, and leg oxygenation/exercise tolerance in patients with peripheral arterial disease (PAD). Understanding and improving blood flow regulation in the heart and skeletal muscles of patients with PAD is important because exercise triggers symptoms of leg pain and substantially raises blood pressure and myocardial demand in these patients.

Start: December 2015

EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS

This study is trying to answer the following research question: "Are there any differences between effects of aerobic training and myofascial release on claudication among peripheral arterial insuffiency patients?

Start: February 2021

Exoskeleton Footwear to Improve Walking

The purpose of this study is to determine the best assistance level of an exoskeleton footwear (EF) that can assist walking for people older than 40 with and without peripheral artery disease (PAD). The test will be performed on two different groups of people for this study that include: 1) people with PAD, and 2) individuals who don't have PAD. Data will be collected from 50 healthy older individuals and 25 patients with PAD, both groups will be 40 years or older. Gait biomechanics, muscle oxygenation, and energy cost for seven different walking conditions including normal walking, walking with EF with no assistance, and walking with EF with 5 different levels of assistance will be collected from the healthy older individuals. Additionally, subject-reported outcomes after each walking conditions including perceived comfort and fatigue, rate of perceived exertion and feasibility of the EF will be collected. Gait biomechanics, muscle oxygenation, energy cost, and patient-reported outcomes will be measured in patients with PAD for four walking conditions including normal walking, walking with EF but no assistance, walking with EF with the best two assistance levels. Subjects will be allowed to acclimate to the EF prior to recording data. All patients with PAD will participate in feasibility interviews that will assess acceptability, demand, implementation, and practicality. All subjects will be asked to fill out questionnaires that assess quality of life, physical function, and the ability to complete activities of daily living.

Start: August 2020

Pulsed Electromagnetic Field Versus Treadmill Walking in Peripheral Arterial Disease

my study is to determine the effect of pulsed electromagnetic field versus treadmill training in managemet of intemittent claudication in peripheral arterial disease there is a lack of interventions that improves local peripheral blood circulation in ischemic lower limbs . (PEMFs) are a non-pharmacological and non-invasive treatment that can be applied on the affected body part, which penetrates through skin and reaches target tissues . However, there have been few clinical studies reporting the effects of PEMFs on hemodynamic response in people with PAD (

Start: December 2018

Safety and Efficacy of Atherectomy on VasculaR Functions

Interventional strategies aim to restore tissue perfusion. However, despite the simple reopening of a narrowed artery they affect endothelial function, perpetuating dysfunctional vascular homeostasis. PTA and atherectomy might alter the endothelial function but the mechanisms are incompletely understood. The primary goal of atherectomy is vessel preparation and improving compliance, which could aid in preserving vessel functions. Aim of this study is to determine safety, efficacy, patency and vessel functions in the femoropopliteal artery following atherectomy and DCB.

Start: January 2019

IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA

To assess the safety and efficacy of the paclitaxel drug-eluting balloon IN.PACT 014 versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.

Start: March 2017

Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT)

An estimated 8 million individuals in America are affected by peripheral arterial disease (PAD), blockages of the leg arteries that can cause excruciating calf pain when walking. PAD can have a tremendous impact on patients' quality of life. It is also associated with high rates of heart attacks and premature death. While there are a number of treatments, there have been few previous studies that have prospectively examined treatment patterns for PAD or sought to systematically identify opportunities to improve care. Most importantly, there have been no rigorous studies examining the impact of the disease from patients' perspectives - their symptoms, function and quality of life - as a function of different patient characteristics and treatments. The PORTRAIT study (Phase II) will systematically document the treatments and health status (symptom, function and quality of life) outcomes of 840 US patients over the course of one year (assessments at baseline, 3, 6, and 12 months) from 10 centers to address these gaps in knowledge. It will illuminate whether disparities in treatment or health status outcomes exist as a function of patients' age, gender, race, socioeconomic or psychological characteristics. PORTRAIT will substantially elevate the field and identify critical gaps in the way PAD is currently managed, including potential disparities in care, so that the quality of care can be improved.

Start: October 2013

Real World Registry Assessing the Clinical Use of the Bard UltraScore Forced Focus PTA Balloon

The objective of this study is to assess the clinical use of the Bard® UltraScore™ Focused Force PTA balloon in a heterogeneous patient population in a real world, on-label clinical application.

Start: March 2018

Validation of the VascuQoL-6 Questionnaire to Assess ePROM After Revascularization for Lower Limb Peripheral Arterial Disease in German-speaking Part of Switzerland

Two hundred patients evaluated to undergo revascularization (elective/emergent, surgical/interventional) for lower limb PAD at the cantonal hospital of Aarau, Switzerland, will, after consenting to participate in the study, be asked to fill up both SF-36 and VascuQol-6 questionnaires while sitting in a waiting room before the procedure and during the 30 days and 1-year routine follow up. An electronic version of the questionnaires will be administered on a tablet. The primary goal is to validate the clinical use of the German electronic version of the VascuQol-6 questionnaire to assess patient-related outcomes of the performed treatment by patients with PAD.

Start: December 2020

Cilostazol Following Peripheral Endovascular Procedures

To compare the safety and effectiveness of dual anti-platelet therapy with cilostazol 100 mg twice daily and aspirin 100 mg daily versus monotherapy with aspirin 100 mg daily in patients undergoing peripheral angioplasty or stenting or both for the management of peripheral arterial disease.

Start: December 2016

GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)

This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.

Start: February 2021

EO2 Oxygen Delivery To Study Success Rate of Surgically Closed Wounds

The investigators will test the efficacy of the novel oxygen diffusion dressing allows delivery tissue oxygenation via TransCu O2® Oxygen Delivery System for use in caring for patients with surgically closed wounds. The investigators hypothesize that using this novel oxygen diffusion dressing will reduce the likelihood of necrotic tissue as well as severe incisional scar post-surgical closure by improving transcutaneous oxygen levels during wound healing process. TransCu O2 Oxygen Delivery System is a novel wound healing therapy that promises to enhance tissue hydration, which in turn may lead to quick epithelialization essential to reduce the likelihood of formation of necrotic tissue and excessive scars.

Start: May 2017

Belgian-Italian Trial to Evaluate the Efficacy and Safety of Below The Knee (BTK) Treatment With the Luminor 14 Paclitaxel Coated Percutaneous Transluminal Angioplasty Balloon Catheter of iVascular

The BIBLIOS trial investigates the efficacy and safety of BTK treatment of patients suffering from critical limb ischemia (Rutherford 5) with the Luminor-14 Paclitaxel coated Percutaneous Transluminal Angioplasty Balloon catheter of iVascular. An expected total of 150 patients will be treated. Infrapopliteal lesions will be treated during this trial. The Paclitaxel eluting balloon Luminor-14 is designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation. The balloon is coated with Paclitaxel intended to avoid cellular proliferation. The drug is released by means of rapid inflation as to release a high dose in a short amount of time. Patients will be invited for a follow-up visit at 1, 6 and 12 months post-procedure. The primary efficacy endpoint is defined as freedom from major adverse limb events, defined as above the ankle target limb amputations or major reintervention to the target lesions at 6 months. The primary safety endpoint is freedom from major adverse limb event at 30 days. The secondary endpoints consist of functional flow in target vessel, freedom from clinically driven target lesion revascularisation, above the ankle amputation free survival and limb salvage at 6 and 12 months, and also procedural success, wound healing status and wound healing time.

Start: November 2018