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Arterial Occlusive Diseases clinical trials

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NCT ID: NCT04911218 Completed - Clinical trials for Coronary Angiography

GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery

Start date: May 10, 2021
Phase: N/A
Study type: Interventional

Transradial approach has become the default arterial access for coronary angiography (CAG) and percutaneous coronary intervention (PCI), mainly due to lower incidence of bleeding compared to transfemoral access.1 However, TRA is not deprived of local access site complications such as radial artery occlusion (RAO), occurring in approximately 5.2% of patients, compartment syndrome, pseudoaneurysm, hematoma, and arteriovenous fistula. Recently, a novel approach has been proposed, the access through the distal radial artery (distal transradial access, dTRA), located in the anatomical snuffbox. Initial studies regarding the dRA have shown feasibility and benefits, including shorter hemostasis time, fewer local access site complications and potentially lower incidence of RAO. GlideSheath Slender is a novel sheath which has a hydrophilic coating and is made of a thinner material than traditional sheaths. As a result, the external diameter of the 5 Fr GlideSheath Slender sheath is 1 Fr lower compared with conventional arterial sheaths. The purpose of the present study was to investigate whether the use of the Slender sheath affects the time of hemostasis, sheath insertion time, crossover rate to conventional radial access, pain associated with the procedure and incidence of local access site complications (RAO, distal radial artery occlusion, fistula, hematoma) in patients undergoing diagnostic angiography through the distal radial artery.

NCT ID: NCT04751708 Completed - Clinical trials for Basilar Artery Occlusion

Endovascular Treatment for Acute Basilar Artery Occlusion

Start date: February 21, 2021
Phase: N/A
Study type: Interventional

Rationale: Recently, two prospective multicenter RCT reported a potential beneficial effect of endovascular thrombectomy (EVT) in patients with an acute symptomatic basilar artery occlusion (BAO). However, the high rate of crossover in BEST study and the long-term of recruitment in BASICS study influenced the validity of the results. Besides, a recently prospective clinical registry with large sample size (BASILAR) showed a significantly beneficial effect of EVT in BAO patients. Objective: To assess the effect of EVT in addition to best medical management (BMM) compared to BMM alone, in patients with BAO, caused by a CTA/MRA confirmed occlusion of the basilar artery on functional and safety outcome. Study design: This is a parallel group, randomized clinical trial of EVT with BMM versus BMM. The trial has observer blind assessment of the primary outcome and of neuro-imaging at baseline and follow up. Study population: Patients with acute ischemic stroke and a confirmed basilar artery occlusion by CTA/MRA. Main study parameters/outcomes: The primary effect parameter will be favourable outcome at day 90 defined as a modified Rankin Score (mRS) of 0-3. The estimate will be adjusted for the known prognostic variables age, pre-stroke mRS, time from onset to randomization, stroke severity (NIHSS) and collaterals and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.

NCT ID: NCT04514575 Completed - Clinical trials for Arterial Occlusive Diseases

Plasma Transfusion in Major Vascular Surgery

Start date: January 1, 1997
Phase:
Study type: Observational

BACKGROUND - Major blood loss is frequent in open repair of ruptured and intact abdominal aortic aneurysm (AAA) as well as in aorto-bifurcated prosthesis insertion due to aortoiliac occlusive disease. - Major blood loss is associated with death, post-operative complications and coagulopathy. - Data from randomized trials in trauma patients indicate that a high plasma to red blood cell (RBC) transfusion ratio reduces 30-day mortality. - No randomized trial data are available for the AAA population. - Observational data demonstrate, that a high plasma:RBC transfusion ratio associates to a lower 30 day mortality. However, the reports are based on small cohorts of 78-165 patients, short term outcomes and lack information on major adverse events such as cardiac and respiratory. - The Danish Vascular Registry (DVR), covering 1996-2018, contains data on approx. 4,400 ruptured and 8,200 intact (elective/symptomatic) AAA repairs, and 5,400 open aortoiliac repairs due to occlusive disease. Expected total count 1997-2018: 17,000. - The Danish Transfusion Database (DTDB), covering approx. 1997-2018, contains information on units of RBCs, plasma and platelets transfused. A unique patient identification number (CPR) allows merging of all data set. OBJECTIVE To identify whether resuscitation with a high plasma to RBC ratio associates to improves survival in open abdominal aortic surgery as compared to a low plasma to RBC-ratio. PICO - Population: Open abdominal aortic surgery - Intervention: "High FFP": FFP to RBC unit ratio of 2:3 to 3:3 (0.7 - 1.0) - Comparison: "Low FFP": FFP to RBC unit ratio of 0:3 to 1:3 (0.0 - 0.3) - Outcome: All-cause mortality 90 days following surgery. DATA SOURCES CPR, Danish Civil Registration System. DNPR, Danish National Patient registry. DVR, Danish Vascular registry. DPDB, The Danish national Prescription DataBase.

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: NCT04238026 Completed - Clinical trials for Radial Artery Occlusion

Distal Radial Artery Approach to Prevent Radial Artery Occlusion (DAPRAO)

DAPRAO
Start date: May 2, 2019
Phase: N/A
Study type: Interventional

The main complication of transradial intervention is radial artery occlusion (RAO). This is relevant because it limits the radial approach for future interventions and disables this conduit for coronary bypass grafts and arteriovenous fistula. Observational studies suggest that distal radial access could reduce RAO incidence. The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence. The safety endpoint is the incidence of complications between these two methods.

NCT ID: NCT04196309 Completed - Arterial Occlusion Clinical Trials

Effect of LOW-molecular-weight Heparin in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization

LOW-RAO
Start date: May 25, 2017
Phase: Phase 4
Study type: Interventional

The purpose of the LOW-RAO study is to determine the most effective treatment for radial artery occlusion (RAO) after transradial coronary catheterization (both angiography and PCI). This is a prospective, single-center, randomized controlled, open-label study that will randomize patients with RAO into two groups, one receiving anticoagulation with low-molecular-weight-heparin (LMWH) and the other receiving no anticoagulation. RAO will be detected by radial artery ultrasound up to 24 hours after the procedure. Study objectives: 1. Primary objective: a. To evaluate the effect of treatment with LMWH, in patients (both symptomatic and asymptomatic) with RAO after a coronary catheterization procedure (both angiography and percutaneous coronary intervention-PCI), in improving patency rates of the radial artery at 1 month after the procedure, compared with no-LMWH treatment. 2. Secondary objectives: 1. To compare RAO as defined by different methods (pulse palpation, modified Allen's test, reverse Barbeau test, radial artery ultrasound). 2. To compare local access site and systemic complications (bleeding events, pseudoaneurysm, arteriovenous fistula) at 1 month after the procedure in the LMWH and no-LMWH groups. 3. To evaluate RAO incidence in coronary angiography and PCI groups. 4. To determine risk factors for RAO in coronary catheterization procedures.

NCT ID: NCT04114838 Completed - Clinical trials for Peripheral Arterial Obstructive Disease

Cohort Study of Patients Treated for Peripheral Arterial Occlusive Disease

EndoRevI
Start date: January 2, 2020
Phase:
Study type: Observational

Peripheral Arterial Occlusive Disease is associated with a high risk of cardiovascular events. The critical ischemia stage represents the most severe stage of Peripheral Arterial Occlusive Disease, associated with decubitus pain and / or foot ulceration. The severity of this arterial involvement involves functional prognosis of the lower limb with a high risk of amputation, and the vital prognosis of the patient. In these patients, the rate of amputation and mortality at 1 year can reach 20%. Therefore, the goal of management in a multidisciplinary setting is limb salvage and improvement of the patient's vital prognosis. In the vascular medicine department, the indication and modalities of the revascularization procedure are discussed in a multidisciplinary consultation meeting. Surgical revascularization by distal bypass requires venous material that can be used, a receiving artery without diffuse lesions, in direct continuity with the arterial network of the foot, and the absence of co-morbidities against general anesthesia. With the modernization and development of endovascular equipment dedicated to the hamstrings, the interventional radiology techniques in the management of critical ischemia allow the treatment of one or more arterial axes as well as a very distal revascularization in the arteries. of the foot with less morbidity-mortality compared to surgery, especially in patients the most fragile patients. Since 2013, the endovascular revascularization procedures performed by the interventional radiology team have been an integral part of the management of patients with peripheral arterial disease of the lower limbs monitored in the vascular medicine department. The hospital is therefore a privileged place to observe the long-term impact of this medical care on the future of patients with different stages of severity of arterial disease. The objective of this retrospective study is to evaluate the life-threatening, limb salvage and associated prognostic factors in patients with Peripheral Arterial Occlusive Disease supported by endovascular revascularization in the vascular medicine department of the GHPSJ.

NCT ID: NCT03898570 Completed - Clinical trials for Cardiovascular Diseases

Distributed Registry

Start date: April 1, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to test if a patient can be directly connected to a quality assurance (QA) database, traditionally known as a registry. Patient-reported outcomes (PRO) data will be entered into the database directly from a patient's mobile phone from their index procedure for 12 months. The investigators hope this study to be a "proof of concept" for such a distributed registry and evaluate 1) consistency of data acquisition, 2) engagement of patients, 3) overall value of patient-reported outcomes to enhance long term follow up.

NCT ID: NCT03856606 Completed - Clinical trials for Cardiovascular Diseases

The Effects of Interrupting Prolonged Sitting With Intermittent Exercise on Postprandial Lipemia

Start date: February 20, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of interrupting prolong sedentary behavior with interval exercise on postprandial metabolism following a high fat glucose tolerance test.

NCT ID: NCT03844724 Completed - Clinical trials for Peripheral Arterial Disease

Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion

Start date: April 10, 2015
Phase: N/A
Study type: Interventional

Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion