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Coronary Disease clinical trials

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NCT ID: NCT02663323 Active, not recruiting - Clinical trials for Coronary Artery Disease

Pilot Clinical Study of MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System

MeRes-1Extend
Start date: February 2, 2016
Phase: N/A
Study type: Interventional

MeRes-1 Extend study is designed as prospective, multinational, multicentre, single arm, open label, pilot study to assess the safety and performance of the MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System (BRS) in subjects with de novo native coronary artery lesions. 64 subjects will be enrolled from the 8 centers located in Asia Pacific, Europe, Brazil and South Africa. Primary outcome of study will be Proportion of population reporting Major Adverse Cardiac Events at 6 months from the day of index Procedure.

NCT ID: NCT02649400 Active, not recruiting - Clinical trials for Coronary Artery Disease

Assessment of Functional Capacity and Inflammatory Markers in Women With Heart Failure With Preserved Ejection Fraction

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

This study assesses the impact of diastolic heart failure on exercise capacity in women who have a previous coronary condition. All the participants will go through the same evaluation.

NCT ID: NCT02579499 Active, not recruiting - Clinical trials for Coronary Artery Diseasse

Low-Density Lipoprotein Cholesterol-targeting Statin Therapy Versus the Intensity-based Statin Therapy in Patients With Coronary Artery Disease

LODESTAR
Start date: September 9, 2016
Phase: Phase 4
Study type: Interventional

To compare clinical safety & efficacy of fixed-high potent statin therapy (according to 2013 ACC/AHA guideline) vs. targeted LDL-C goal statin therapy (LDL<70mg/dL) for secondary prevention. Total 4400 patients with coronary artery disease patients requiring statin treatment were categorized fixed high-potent statin group and targeted LDL-C group. The investigators will compare primary endpoint (major adverse cardiac and cerebrovascular event (MACCE)) and secondary endpoint (1. New onset diabetes mellitus after randomization, 2. Hospitalization due to heart failure, 3. Deep vein thrombosis or Pulmonary thromboembolism, 4. Percutaneous trans-luminal angioplasty on peripheral artery obstructive disease, 5. Aortic intervention or operation, 6. ESRD with renal replacement therapy).

NCT ID: NCT02577484 Active, not recruiting - Clinical trials for Coronary Artery Disease

Assessment of Catheter-based Interrogation and Standard Techniques for Fractional Flow Reserve Measurement

ACIST-FFR
Start date: November 2015
Phase: N/A
Study type: Observational

This study will assess the differences between Fractional Flow Reserve (FFR) measurements made by the Navvus catheter and a commercially available pressure guidewire in up to 240 subjects where FFR is clinically indicated. All subjects will receive diagnostic treatment according to clinical indications and center standard practice.

NCT ID: NCT02568462 Active, not recruiting - Clinical trials for Coronary Artery Disease

Safety and Efficacy Study of the Amaranth Medical APTITUDE Bioresorbable Drug-Eluting Coronary Stent

RENASCENT II
Start date: November 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and performance of a new version of a coronary artery stent for treating blockages in the arteries supplying blood to the heart muscle. The Amaranth Medical APTITUDE scaffold releases a drug (sirolimus) to reduce the likelihood of the treated blood vessel developing a new blockage. In addition, the scaffold dissolves away over time, leaving no permanent implant after the blood vessel has healed.

NCT ID: NCT02520921 Active, not recruiting - Obesity Clinical Trials

Aspirin Twice a Day in Patients With Diabetes and Acute Coronary Syndrome

ANDAMAN
Start date: June 13, 2016
Phase: Phase 4
Study type: Interventional

To compare treatment with Aspirin Protect® twice a day (100 mg in the morning and 100 mg in the evening) versus Aspirin Protect® 100 mg once per day on a composite end-point of ischemic events in diabetic patients, or in patients with a known risk factor for non-optimal aspirin response (obesity, abdominal obesity or coronary event occurring with long-term aspirin),with acute coronary syndrome. It is expected that aspirin taken twice a day will reduce the occurrence of new ischemic event after acute coronary syndrome in diabetic patients or in patients with a known risk factor.

NCT ID: NCT02508714 Active, not recruiting - Clinical trials for Coronary Artery Disease

Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents

BIONYX
Start date: October 7, 2016
Phase: N/A
Study type: Interventional

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.

NCT ID: NCT02468960 Active, not recruiting - Clinical trials for Coronary Artery Disease

Optimal Lesion Preparation With Non-compliant Balloons Before Implantation Of Bioresorbable Scaffolds (OPreNBiS)

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

Study aim : To compare a novel strategy of lesion preparation with noncompliant balloons before implantation of BVS (Bioresorbable Vascular Scaffold). Hypothesis: Predilatation with non-compliant balloons could facilitate optimal deployment of BVS. By achieving good scaffold apposition a need for post-dilatation could be significantly reduced. This is expected to result in better short- and long-term outcomes.

NCT ID: NCT02448524 Active, not recruiting - Clinical trials for Coronary Heart Disease

Clinical Trial on the Efficacy and Safety of Sirolimus-Eluting Stent (MiStent® System)

DESSOLVE-C
Start date: July 2015
Phase: Phase 3
Study type: Interventional

- To evaluate the safety and efficacy of MiStent drug (sirolimus)-eluting stent system in the treatment of coronary heart disease (CHD) in patients with primary in situ CHD (de novo); - To evaluate operating performance of the MiStent drug (sirolimus)-eluting coronary stent system.

NCT ID: NCT02400229 Active, not recruiting - Clinical trials for Coronary Artery Disease

Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease

DISCHARGE
Start date: October 3, 2015
Phase: N/A
Study type: Interventional

The primary hypothesis is that computed tomography (CT) is superior to invasive coronary angiography (ICA) concerning the primary endpoint MACE (MACE = major adverse cardiovascular event; defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) after a maximum follow-up of 4 years, in other words, that CT will result in a significantly lower rate of MACE. Secondary outcomes include MICE (MICE = minor cardiovascular events), procedural complications, cost-effectiveness, radiation exposure, cross-over to CT or ICA, gender differences, and health-related quality of life.