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Ischemia clinical trials

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NCT ID: NCT02516072 Completed - Clinical trials for Contrast Induced Nephropathy

Use of Remote Ischaemic Preconditioning in the Prevention of Contrast Induced Nephropathy

Start date: January 2015
Phase: N/A
Study type: Interventional

With an increasingly ageing population the incidence of peripheral arterial disease (PAD) is rising. With approximately one quarter of all PAD patients ultimately progressing to Critical Limb Ischaemia (CLI), increased demands are being placed on vascular imaging to accurately assess stenotic lesions. Early infrainguinal lesions (i.e. TASC A & B) can be treated with angioplasty+/- stenting and accurate assessment relies on the imaging gold standard of angiography. Patients with PAD often have concomitant co morbidities such as diabetes and chronic renal impairment placing them at increased risk of developing contrast induced nephropathy (CIN) when exposed to iodinated contrast media. High risk individuals with decreased eGFR <60ml/min have a risk of between 20-30% of developing CIN. They have increased morbidity and mortality risks with a greater need for dialysis and prolonged in patient hospital stays. Ideally, the investigators should be searching for ways to decrease the incidence of CIN. Animal studies and more recently pilot human trials have shown that subjecting a remote vascular bed to a brief ischaemic stress, followed by a period of reperfusion; in what has been termed remote ischemic preconditioning (RIPC), may confer a protective benefit against the development of CIN. This study aims to determine if RIPC can protect against CIN in patients undergoing elective peripheral angiography for infrainguinal disease.

NCT ID: NCT02514460 Completed - Atherosclerosis Clinical Trials

Clinical Study of Stent Versus Direct Atherectomy to Treat Lower Limb Ischemia

Start date: January 2014
Phase: N/A
Study type: Interventional

This is a randomized study comparing stent and plaque excision systems in treatment of lower limb (superficial femoral or popliteal artery) ischemia.

NCT ID: NCT02513732 Completed - Clinical trials for Coronary Artery Disease

XIENCE Xpedition Everolimus-Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE Xpedition SV Japan PMS)

Start date: July 2014
Phase:
Study type: Observational

The objective of the study is to evaluate the safety and efficacy of XIENCE Xpedition Everolimus-Eluting 2.25mm Stent in real world practice in Japanese hospitals.

NCT ID: NCT02513719 Completed - Clinical trials for Coronary Artery Disease

XIENCE PRIME SV Everolimus Eluting Coronary Stent Japan Post Marketing Surveillance (XIENCE PRIME SV Japan PMS)

Start date: May 13, 2013
Phase:
Study type: Observational

The objective of the study is to evaluate the safety and efficacy of XIENCE PRIME SV in real world practice in Japanese hospitals.

NCT ID: NCT02510547 Completed - Clinical trials for Coronary Artery Disease

Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial

Start date: September 2015
Phase: Phase 4
Study type: Interventional

CrossBoss First is a single-blind randomized controlled trial that will randomize 246 patients undergoing clinically-indicated Chronic Total Occlusion Percutaneous Coronary Intervention, to upfront use of the CrossBoss catheter vs. antegrade guidewire escalation strategy The "CrossBoss First" study has two primary objectives. The primary efficacy objective is to compare the procedure time required to cross the CTO or abort the procedure with a CrossBoss first vs. antegrade wire escalation strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be associated with shorter procedure time required for CTO crossing compared with an antegrade wire escalation strategy. The primary safety objective is to compare the frequency of procedural major adverse cardiovascular events (MACE) with upfront use of CrossBoss vs. a guidewire escalation strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be associated with similar incidence of MACE compared with an antegrade wire escalation strategy. The secondary endpoints are: (1) technical and procedural success4-6; (2) total procedure time (defined as the interval between administration of local anesthesia for obtaining vascular access and removal of the last catheter); (3) fluoroscopy time to cross the CTO and total fluoroscopy time; (4) total air kerma radiation exposure; (5) total contrast volume; and (6) number of wires, microcatheters, balloons, and stents used.

NCT ID: NCT02507856 Completed - Clinical trials for Transient Ischemic Attack With Non-valvular Atrial Fibrillation

Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA

PRODAST
Start date: July 2015
Phase:
Study type: Observational [Patient Registry]

The multi-center, prospective PRODAST study is investigating patients with non-valvular atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. It consists of a baseline visit and a 3 months central follow-up for patients who were discharged with dabigatran, vitamin K-antagonists, antiplatelets only, or no oral antithrombotic treatment at all. Thus, data on the use of dabigatran and vitamin K-antagonists in routine clinical practice will be collected to describe how dabigatran is prescribed and used in the population of AF patients with recent cerebrovascular events and how these factors influence important outcome and safety events. The utilization of dabigatran will be assessed with regards to treatment persistence, compliance, proportion of patients discontinuing treatment and reason for discontinuation as well clinical endpoints such as major bleeding, stroke or systemic embolism. Due to the fact that patients will be treated according to local medical practice it is possible that medication will be changed during the observation period. In the follow-up, data from the first as well as from the second prescribed medication will be used in the study. To explore a long-term effect of anticoagulation, survival up to one year will be assessed.

NCT ID: NCT02506140 Completed - Stroke Clinical Trials

Platelet Reactivity in Acute Non-disabling Cerebrovascular Events

PRINCE
Start date: August 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Ticagrelor is a reversible and direct-acting oral antagonist of the P2Y12 (Purinergic receptor P2Y, G-protein coupled, 12) receptor for adenosine diphosphate, which provides faster, greater, and more consistent P2Y12 inhibition than Clopidogrel in patients with acute coronary syndrome, irrespective of the genetic variants affecting Clopidogrel metabolism. It is still undefined whether combination therapy of Ticagrelor and Aspirin is more effective than Clopidogrel and aspirin for minor stroke and transient ischemic attack (TIA). The primary purpose of the PRINCE trial is to evaluate the anti-platelet effects of a 3-month regimen of ticagrelor initiated with 180 mg loading dose followed by 90 mg twice/day combined with aspirin 100 mg/day during first 21 days versus a 3-month regimen of clopidogrel initiated with 300 mg loading dose of followed by 75 mg/day combined with aspirin 100 mg/day during first 21 days when initiated within 24 hours of symptom onset in high-risk transient ischemic attack or minor stroke.

NCT ID: NCT02505295 Completed - Ischemic Stroke Clinical Trials

Selenium and Ischemic Stroke Outcome

Start date: October 2015
Phase: N/A
Study type: Interventional

Selenium is a trace element essential to human health.Selenium protection against cellular damage by oxygen radicals is accomplished through selenoproteins. Ischemic stroke is associated with the generation of oxygen free radicals resulting in a condition of oxidative stress. Supplementing stroke patients with antioxidant nutrients may improve survival.

NCT ID: NCT02501018 Completed - Clinical trials for Critical Limb Ischemia

Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI)

Start date: November 1, 2017
Phase: Phase 2
Study type: Interventional

A prospective, open label, controlled, randomized, double arm, multi-center study to assess the efficacy and safety of CLBS12 in patients with critical limb ischemia (CLI) due to arteriosclerosis obliterans (ASO) with a single arm sub-study to assess the safety and potential efficacy of CLBS12 in patients with CLI due to Buerger's Disease (BD).

NCT ID: NCT02488915 Completed - Stroke Clinical Trials

Analysis of Revascularization in Ischemic Stroke With EmboTrap

ARISEII
Start date: November 2015
Phase: N/A
Study type: Interventional

The study objective is to examine the recanalization efficacy of the EmboTrap device and its associated performance characteristics and to record associated clinical outcomes in a manner that facilitates relevant comparison of outputs with that of devices approved in the U.S. for clearing Large Vessel Occlusions.