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Coronary Restenosis clinical trials

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NCT ID: NCT00627900 Completed - Clinical trials for Coronary Artery Disease

Cost-Effectiveness Study in the Reduction of Coronary Restenosis With Sirolimus-Eluting Stents

GERSHWIN
Start date: April 2003
Phase: Phase 4
Study type: Interventional

Since the advent of coronary stents, in-stent restenosis has proven to be the major limitation of interventional cardiology, occurring in as many as 30% of patients. Drug-eluting stents are specifically designed to prevent the problem of in-stent restenosis. They consist of a selective anti-proliferative drug, sirolimus, a controlled-release polymer, and a closed-cell stent delivery platform. Upon placement, sirolimus elutes into the vessel wall and stops the process of neointimal hyperplasia, thereby significantly reducing the incidence of in-stent restenosis. The study "Prevention of Coronary Restenosis" examines the effectiveness of sirolimus-eluting stents (SES) compared to bare-metal stents (BMS) in patients with coronary stenosis. The goal of the study is to examine whether the guideline-supported implantation of SES, despite the higher initial cost, improves the quality and economic outcomes of the treatment of patients with coronary stenosis. Secondarily, the study evaluates patient quality of life, impairment of daily activities, re-intervention rate, as well as an account of the utilisation and benefits of the implemented standardised guidelines. In this prospective, multi-centre, country-wide cohort study, 658 patients undergoing an implantation of a SES for treatment of coronary stenosis were recruited from 35 hospital centres. Their treatment and outcomes will be evaluated over a 3-year period by means of standardised questionnaires. In addition, information obtained from the patients will be confirmed and augmented by telephone interviews with the attending physicians involved in their follow-up care. In order to appraise the effect of the new therapy, a comparison cohort group of 394 patients receiving a BMS was recruited. These patients will be evaluated and observed by the same method as those patients receiving a drug-eluting stent, also over 3 years

NCT ID: NCT00598533 Completed - Clinical trials for Coronary Heart Disease

Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis

ISAR-TEST-5
Start date: February 2008
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis

NCT ID: NCT00589810 Completed - Coronary Restenosis Clinical Trials

Whole Genome Association Study to Identify and Validate Genes for Restenosis: CardioGene Validation Proposal

Start date: August 2007
Phase: N/A
Study type: Observational

In this replication study at the Cleveland Clinic, we seek to collaborate to validate findings of the CardioGene Study in an independent cohort of patients who have undergone bare metallic stenting.

NCT ID: NCT00552669 Completed - Clinical trials for Coronary Heart Disease

Study of Oral Rapamycin Plus Bare Metal Stents vs Drug Eltuting Stents

ORAR III
Start date: January 2006
Phase: Phase 4
Study type: Interventional

In a previous randomized comparison oral sirolimus plus bare metal stent compared to bare metal stent implantation alone demonstrated at one year of follow up a significant reduction of angiographic and clinical parameters of restenosis (ANMAT resolution number 3366 from June 2004 and Rodriguez A et al JACC,2006,47,1522-1529). In addition previous reported registries from our group with Drug Eluting Stents showed similar amount of reduction in clinical parameters (not angiographic)of restenosis (ERACI III, Rodriguez A et al EuroIntervention 2006,2:53-60). Taking in account that 8.3% of patients treated with oral rapamycin plus Bare Metal Stents(ORAR II Trial JACC 2006)and 8.8% of patients treated with DES developed clinical restenosis (ERACI III Registry, EuroIntervention 2006) the investigators sought to compare differences in overall cost with both revascularization strategies at 1, 2, 3 and 5 years of follow up assuming that safety and efficacy clinical end points would be similar.

NCT ID: NCT00531011 Completed - Clinical trials for Coronary Artery Disease

EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease

EXecutive
Start date: September 2007
Phase: Phase 4
Study type: Interventional

The purpose of this two part study is the assessment of the performance of the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in the treatment of the specific setting of patients with Multi-Vessel Coronary Artery Disease (MVD).

NCT ID: NCT00500279 Recruiting - Coronary Restenosis Clinical Trials

Effects of Celecoxib On Restenosis After Coronary Intervention and Evolution of Atherosclerosis Trial

mini-COREA
Start date: November 2006
Phase: Phase 4
Study type: Interventional

To evaluate the effect of celecoxib use for 3 month after drug-eluting stent implantation - on restenosis - on clinical outcome such as target lesion revascularization, thrombotic event, myocardial infarction, death - on inflammatory biomarkers

NCT ID: NCT00496938 Completed - Clinical trials for Coronary Artery Disease

XIENCE V: SPIRIT WOMEN

Start date: July 2007
Phase: Phase 4
Study type: Interventional

The purpose of this Clinical Evaluation is the continued assessment of the XIENCE Everolimus Eluting Coronary Stent System (XIENCE V® and XIENCE PRIME™ EECSS) with the primary focus on clinical outcomes in the treatment of female patients with de novo coronary artery lesions, and the characterization of the female population undergoing stent implantation with a XIENCE stent.

NCT ID: NCT00426049 Recruiting - Clinical trials for Coronary Artery Disease

Systemic Treatment With Everolimus for the Prevention of MACE After Bare Metal Stent Implantation

Start date: October 2006
Phase: Phase 3
Study type: Interventional

The purpose of the present study is to provide the first in-human safety and efficacy evaluations of systemic oral anti-proliferative Everolimus therapy compared to placebo in patients treated by bare metal stents for significant coronary artery disease. The aim is to reduce Major Adverse Cardiac Events (MACEs) including death, coronary artery bypass grafting (CABG) to the target vessel, Q-wave and non-Q-wave myocardial infarction, and target lesion revascularization within the first 6 months after intervention. Additionally safety and tolerability of Everolimus at the selected dose in this patient population will be analyzed.

NCT ID: NCT00412126 Completed - Diabetes Mellitus Clinical Trials

Clinical and Angiographic Outcomes With Hyperglycemic Control Post PCI

Start date: July 2002
Phase: N/A
Study type: Interventional

Coronary artery disease is a process that results in “hardening of the arteries”. When the arteries that supply blood and oxygen to your heart muscle become clogged or narrowed, a heart attack may result, or you may feel chest discomfort (angina) – sometimes even while resting. One approach to treating this condition is a balloon procedure known as coronary angioplasty. The major limitation of coronary angioplasty is renarrowing of the artery (restenosis) in the first six months following the procedure requiring either repeat angioplasty or referral for bypass surgery. Patients with diabetes have always been identified as having higher rates of restenosis and poor outcomes following angioplasty, despite some important scientific advances. We think that the level of blood sugar control at the time of angioplasty and in the following months may be related to the extent of restenosis. We expect that a reduction in blood sugar with insulin may, in turn, reduce the restenosis process and improve your long-term outcome.

NCT ID: NCT00409981 Completed - Coronary Restenosis Clinical Trials

Treatment of in-Stent Restenosis by Paclitaxel Coated PTCA Balloons (PACCOCATH – ISR II)

Start date: July 2004
Phase: Phase 1/Phase 2
Study type: Interventional

The PACCOCATH ISR II study is a randomized, double-blinded German multicenter trial on the efficacy and tolerance of a paclitaxel coated balloon catheter in coronary in-stent restenosis.