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Peripheral Vascular Diseases clinical trials

View clinical trials related to Peripheral Vascular Diseases.

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NCT ID: NCT04276311 Active, not recruiting - Clinical trials for Peripheral Vascular Diseases

Efficacy of Rotational Atherectomy System Associated With Drug Coated Balloon Angioplasty in Limb Ischemia

ELLIPSE
Start date: March 4, 2020
Phase: N/A
Study type: Interventional

Lower extremity peripheral artery disease (PAD) is a major health problem leading to significant morbidity and even mortality. Patients with superficial femoral artery stenosis make up an important proportion of patients with PAD, and since this type of involvement was reported to be most commonly associated with intermittent claudication, this patient population has been subject to intensive research on methods to prevent disease progression and further complications. Endovascular treatment has become the first-line treatment for low-complexity femoropopliteal (FP) lesions classified as TASC (Trans Atlantic Inter-Societal Consensus) A and B. Conversely, in case of more extensive lesions (TASC C), this treatment is still under debate because of a primary permeability that is difficult to maintain over time. Recently, studies have shown the interest of drug eluting technologies in the treatment of TASC A & B femoral-popliteal lesions, by significantly improving patency rates compared to uncoated balloons or stents. In this context, the endovascular treatment of FP complex lesions (TASC C) continues to develop widely. During endovascular treatment, the quality of the artery preparation has recently been identified as a factor improving outcomes. The dilatation of the artery with an uncoated balloon or POBA (Plain Old Balloon Angioplasty) is the reference method performed before stent placement or drug-coated balloons. However, some new alternatives to prepare the artery have emerged, using no more dilatation but atherectomy (Jetstream™ system). Atherectomy appears to reduce the risk of dissections and bailout stenting and improve the acute procedural results. Its long term outcome, when associated with drug coated balloons (DCB), has recently been demonstrated in the USA to be superior to angioplasty in a single center study JET-SCE. The purpose of this study is to evaluate the efficacy and the feasibility of atherectomy, using the Jetstream™ artery preparation associated to DCB treatment (Ranger™ Paclitaxel-Coated balloon), in symptomatic patients with claudication (Rutherford 2 and 3) and with complex de novo FP arterial lesions (TASC C).

NCT ID: NCT04275323 Recruiting - Clinical trials for Peripheral Vascular Disease

Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-1)

Start date: August 2, 2019
Phase: Phase 3
Study type: Interventional

To evaluate the safety and efficacy of recombinant human hepatocyte growth factor (HGF) bare plasmid injection for local intramuscular injection in the treatment of patients with severe lower limb hemorrhagic disease (Rutherford grade 4)

NCT ID: NCT04274049 Completed - Clinical trials for Peripheral Vascular Disease

Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NL003-CLI-III-2)

Start date: August 18, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether intramuscular injections of NL003 into the calf is safe and effective in the treatment of critical limb ischemia

NCT ID: NCT04269863 Not yet recruiting - Clinical trials for Peripheral Arterial Disease

Personalizing Aspirin Therapy in Peripheral Arterial Disease Patients

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Antiplatelet therapies are important to decrease the morbidity and mortality associated with Peripheral Arterial Disease (PAD) through the prevention of thrombus formation. Aspirin (ASA) is a readily available and affordable antiplatelet medication that can help reduce adverse cardiovascular events by up to 25%. However, 25-60% of PAD patients are "ASA insensitive" having a lower than normal ability to inhibit platelet aggregation after standard aspirin dosing. In a previous study conducted by our lab, we were able to demonstrate a methodology for personalizing antiplatelet therapy using two platelet function tests, Platelet Function Analyzer-100 (PFA 100) and Light Transmission Aggregometry (LTA). To investigate this methodology further, we would like to conduct a pilot study on two cohorts of patients, one population continuing with their current medications (81mg ASA), and a second group who will get personalized antiplatelet therapy using our methodology (81-325mg ASA). In this study, 150 PAD patients taking 81mg Aspirin therapy presenting for clinical follow-up, or in-patient intervention, in vascular clinics or the emergency room, will be recruited to our study. 75 patients will be randomly assigned undergo platelet analysis using PFA-200 and LTA, and will have their antiplatelet therapy personalized. Patients will then be followed up in order to see if the patients with personalized therapy have better platelet inhibition. This study will allow us to help personalize antiplatelet therapy in PAD patients, allowing for better patient outcomes and decreased adverse cardiovascular events.

NCT ID: NCT04250675 Completed - Clinical trials for Peripheral Arterial Disease

Intermittent Pneumatic Compression to Improve Revascularization Outcome

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate whether daily treatment with intermittent pneumatic leg compressions (IPC) following a nonsurgical vascular procedure improves circulation and enhances walking distance.

NCT ID: NCT04241224 Completed - Clinical trials for Peripheral Arterial Disease

A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages

Start date: February 26, 2020
Phase: N/A
Study type: Interventional

To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.

NCT ID: NCT04238923 Not yet recruiting - Vascular Diseases Clinical Trials

Topical Gentamicin and Vancomycin for Vascular Surgical Site Infection Prophylaxis

Start date: May 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Many patients who undergo vascular surgery to improve the blood flow to their legs are at risk of developing an infection in the surgical site and are then at risk of serious complications such as hospital readmission, failure of the surgical procedure and lower limb amputation. Surgical site infections may be reduced in high-risk patients by applying two commonly used antibiotics (gentamicin and vancomycin) into the surgical incision at the end of the surgical procedure. This will be compared to the standard of care treatment at London Health Sciences Center.

NCT ID: NCT04238546 Recruiting - Clinical trials for Peripheral Arterial Disease

Major Adverse Limb Events in Patients With Femoro-popliteal and Below-the-knee Peripheral Arterial Disease Treated With Either Sirolimus-coated Balloon or Standard Uncoated Balloon Angioplasty

Start date: November 3, 2020
Phase: N/A
Study type: Interventional

The SirPAD trial is an academic, investigator-initiated, single-center, randomized, non-inferiority, open-label clinical trial investigating whether the use of sirolimus-coated balloon catheters in patients with peripheral artery disease of the femoro-popliteal or below-the-knee segment is not inferior to that of uncoated balloon catheters for major clinical outcomes (unplanned major amputation, target limb re-vascularization) and may provide advantages concerning important secondary outcomes, which will be evaluated using a pre-specified hierarchical order as part of the primary analysis.

NCT ID: NCT04229563 Active, not recruiting - Clinical trials for Peripheral Arterial Disease

Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease

PATHFINDER-I
Start date: August 4, 2020
Phase:
Study type: Observational [Patient Registry]

The PATHFINDER I Registry is a prospective, non-randomized, single arm, multicenter observational study. It is a pilot registry study towards a subsequent large pivotal phase registry. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the AURYON™ Atherectomy System, within the initial launch phase of the product in the market.

NCT ID: NCT04228549 Terminated - Clinical trials for Peripheral Arterial Disease

MyPADMGT Support of Out-Patients With Peripheral Arterial Disease

Final_PADHSS
Start date: February 24, 2021
Phase: N/A
Study type: Interventional

The investigators have developed an online program to help people with peripheral arterial disease (PAD) in their extremities to better self-manage their condition. Some earlier testing has been done and the investigators now wish to try this system with participants who have this blood vessel disease as well as high blood pressure. Investigators are hoping to help these participants to achieve healthier lifestyles and improve their quality of life through education, monitoring and continuing support. A similar online desk-top version with over 30 participants has been tested at St. Michael's Hospital in Toronto. The investigators propose to test this newer mobile system with 210 outpatient participants from Hamilton General Hospital. Data collected will be analyzed following the (12 months for each participant) study, along with data recorded during clinical visits at baseline and twelve months for each participant. The objective is to evaluate changes to participant health and determine whether the health self-management process has been successful in improving participant lifestyles and quality of life, when compared to usual care.