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Ischemia clinical trials

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NCT ID: NCT02052427 Completed - Myocardial Ischemia Clinical Trials

Safety & Efficacy of Adipose-Derived Regenerative Cells in the Treatment of Chronic Myocardial Ischemia (ATHENA II)

ATHENA II
Start date: January 2014
Phase: Phase 2
Study type: Interventional

This is a prospective, randomized, placebo-controlled, double blind safety and efficacy clinical trial.

NCT ID: NCT02051088 Active, not recruiting - Clinical trials for Peripheral Arterial Disease

Swedish Drug-elution Trial in Peripheral Arterial Disease

SWEDEPAD
Start date: November 2014
Phase: N/A
Study type: Interventional

Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation). In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies. In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.

NCT ID: NCT02046226 Terminated - Clinical trials for Critical Limb Ischemia

Dissolved Oxygen Dressing to Improve Chronic Wound Healing After Revascularization for Critical Limb Ischemia

Start date: August 2013
Phase: N/A
Study type: Interventional

A Prospective, Randomized, Single-center Pilot Study of The OxyGenesys(TM) Dissolved Oxygen Dressing to Improve Chronic Wound Healing after REvascularization for Critical Limb Ischemia.

NCT ID: NCT02045212 Completed - Clinical trials for Non-arteritic Ischemic Optic Neuropathy

Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).

Start date: February 2014
Phase: Phase 2
Study type: Interventional

The study objectives are to assess any changes in visual acuity and visual field observed following the administration of RPh201 during an overall treatment period of at least 13 consecutive weeks with an option to extended the treatment phase to another 13 weeks (26 weeks total), and at the follow-up visit at 3 month after end of treatment in patients with optic nerve neuropathy.

NCT ID: NCT02044666 Completed - Clinical trials for Peripheral Arterial Disease

Cook Micronized Small Intestinal Submucosa (SIS) for Critical Limb Ischemia

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

This study is intended to collect safety and effectiveness data on the Cook Micronized Small Intestinal Submucosa (SIS)

NCT ID: NCT02044003 Completed - Clinical trials for Peripheral Artery Disease

Safety & Feasibility Study of Tack-It Device for Vessel Dissection Repair

Start date: December 2009
Phase: N/A
Study type: Interventional

The study is intended to evaluate the safety and feasibility of using the Intact Vascular (Innovasc) Tack-It Endovascular Dissection Repair System (Tack Intravascular Staple System) in patients with vascular flaps in the infrainguinal due post-angioplasty dissection.

NCT ID: NCT02043795 Completed - Clinical trials for Critical Limb Ischemia

Drug Impregnated Bioabsorbable Stent in Asian Population Extremity Arterial Revascularization (DISAPEAR Study)

DISAPEAR
Start date: July 1, 2013
Phase: N/A
Study type: Interventional

The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular) in subjects with critical limb ischemia (CLI) following percutaneous transluminal angioplasty (PTA) of the tibial arteries.

NCT ID: NCT02042534 Completed - Ischemic Stroke Clinical Trials

Rivaroxaban Versus Warfarin in Acute Ischemic Stroke With Atrial Fibrillation

TripleAXEL
Start date: January 2014
Phase: Phase 2
Study type: Interventional

Rationale Acute ischemic stroke due to atrial fibrillation (AF) carries a high risk for early recurrence. In acute stage, guidelines recommend aspirin, but do not recommend anticoagulation due to the increased risk of intracranial bleeding. Since, aspirin has a limited efficacy of preventing recurrent stroke in AF, expert consensus suggests early anticoagulation in non-severe stroke with AF. The current practice for acute ischemic stroke patients with AF is delayed warfarin administration with aspirin use for non-minor stroke or immediate warfarin administration (sometimes with heparin bridging) for minor stroke. However, conventional anticoagulation with warfarin in acute ischemic stroke with AF has the following limitations: 1) risk of intracranial bleeding particularly in acute stage, 2) delayed action and transient paradoxical thrombogenic tendency due to the inhibition of protein C, resulting in the risk of early recurrent embolic stroke, and 3) prolongation of hospitalization waiting for full anticoagulation. In contrast, as compared to warfarin, rivaroxaban is advantageous for reduced risk of intracranial bleeding and immediate anticoagulation efficacy. Goal The current trial will examine whether early initiation (within 5 days from stroke onset) of rivaroxaban as compared to conventional warfarin would reduce intracranial bleeding, recurrent embolic stroke, and hospital stay in patients with acute ischemic stroke due to AF.

NCT ID: NCT02041169 Completed - Clinical trials for Intermittent Claudication

Lower Extremity Peripheral Arterial Disease and Exercise Ischemia

CLASH
Start date: September 2014
Phase: N/A
Study type: Interventional

Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life. Despite maintaining a sufficient walking activity is essential for these patients, LEPAD patients lower their physical activity, which worsen the disease and potentially contribute to increase the risk of cardiovascular events and deaths. In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high variability of the patients' walking capacity (i.e., walking distances between two stops induced by lower limbs pain). Results suggested that in most patients previous stop duration before each walk was a predictor parameter of this walking variability. Whether there is an optimal or minimal recovery time influencing the walking capacity in LEPAD patients has never been studied. This study is a prospective, cross-sectional study in exercise pathophysiology. The main goal is to determine, following a walk that induces ischemia, the influence of the recovery duration on the subsequent walking performance in LEPAD patients. Secondary goals are : 1. To determine the nature of the relationship between the recovery duration and subsequent walking performance. 2. To study the relationship between exercise ischemia, pain evolution and previous recovery duration. 3. To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration. 4. To study the influence of recovery duration on walking capacity from community-based measurement.

NCT ID: NCT02040259 Completed - Ischemic Stroke Clinical Trials

Trevo® Retriever Registry Post Market Surveillance

Start date: November 25, 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of the Trevo® Retriever Registry is to collect real world performance data of the Trevo Retriever which is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.