View clinical trials related to Coronary Restenosis.
Filter by:The ABSORB EXTEND trial is to continue the assessment of the safety and performance of the ABSORB Bioresorbable Vascular Scaffold (BVS) System ABSORB BVS is currently in development at Abbott Vascular.
The primary objective of this study is to evaluate the safety and efficacy of the paclitaxel releasing balloon in patients with in-stent restenosis in a coronary artery.
To evaluate the safety and effectiveness of the XIENCE PRIME and XIENCE PRIME Long Lesion (LL) Everolimus Eluting Coronary Stent System (EECSS) in improving coronary luminal diameter in subjects with symptomatic heart disease due to a maximum of two de novo native coronary artery lesions, each in a different epicardial vessel.
Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.
Despite recent advances in interventional cardiology including the success of drug-eluting stents in de-novo coronary lesions, the treatment of in-stent restenosis remains a challenging clinical issue. Given the efficacy of the systemic sirolimus administration to prevent neointimal hyperplasia in animal models and to halt and even reverse the progression of allograft vasculopathy, the aim of the present double-blind, placebo-controlled study was to evaluate the efficacy of a 10-day oral sirolimus treatment with two different loading regimens for the prevention of recurrent restenosis in patients with in-stent restenosis.
The purpose of this study is to assess the safety and performance of the BVS Everolimus Eluting Coronary Stent System (EECSS) in the treatment of patients with a maximum of two de novo native coronary artery lesions located in two different major epicardial vessels. Currently in development at Abbott Vascular. Not available for sale in the United States.
Objectives: PRIMARY OBJECTIVE: To compare the in-stent late loss at 9 months of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents. SECONDARY OBJECTIVES: Safety: To compare the occurrence of Major Adverse Cardiac Events (MACE) at 30 days, 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms. To compare the occurrence de Serious Adverse Events (SAEs) within 5 years among the paclitaxel, sirolimus and control study arms. To compare the occurrence of in-stent thrombosis within 5 years among the paclitaxel, sirolimus and control study arms. Efficacy: To compare the rate of angiographic success among the study groups To compare the rate of procedural success among the study groups To compare the incidence of clinically driven target lesion revascularization at 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms. To compare the incidence of clinically driven target vessel revascularization at 9 months, 1 year, 3 years and 5 years among the paclitaxel, sirolimus and control study arms. To compare the 1-year, 3-year and 5-year cost-effectiveness profile of the paclitaxel, sirolimus and control study arms. To compare the 9-month in-stent late loss of paclitaxel-eluting stents to the in-stent late loss of sirolimus-eluting stents To compare the 9-month in-segment late loss among the study groups To compare the 9-month in-stent and in-segment binary restenosis rate among the study groups To compare the IVUS percent neointimal obstruction among the study groups Study Design: In the present RANDOMIZED study, the paclitaxel-eluting stent Infinnium® and the sirolimus-eluting stent Supralimus® will be compared to a metallic stent with the same structure (Milennium Matrix®) but without drug elution for the treatment of de novo lesions in native coronaries. The study will be a multicenter clinical trial and will include patients for the treatment with one of the three study stents. In total, 275 patients will be enrolled, randomly allocated for the Infinnium®, Supralimus®, or Milennium Matrix® stents in a 2:2:1 proportion. Patients will be followed-up for 12 months after the index procedure. All patients will undergo a follow-up angiography at 9 months. A subgroup of 55 patients will be evaluated at 9 months with IVUS examination. Treatment: Patients will be treated, according to the randomization groups, with Infinnium®, Supralimus®, or Milennium Matrix® stents of 19 mm, 23 mm, or 29 mm and nominal diameters of 2.5, 3.0, and 3.5 mm.
This study is a prospective, non-randomized, open-label registry of consecutive patients with CAD treated by stent-assisted PCI using at least one CypherTM stent. Up to 1000 pts will be included in the registry. The registry is conducted for the evaluation of the impact of CypherTM Sirolimus-eluting stent implantation in the "real world" of interventional cardiology. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study specific procedures. Consecutive patients treated with the use of the CypherTM stent will be included in the registry. Baseline and post-procedure blood samples will be used to perform platelet function analysis using the Accumetrics Ultegra RPFA (Rapid Platelet Function Assay). All patients will be followed from enrollment through the hospital discharge for any clinically significant event (death, myocardial infarction, TLR, TVR, major or minor bleeding). A follow-up telephone assessment of death, myocardial infarction, revascularization, and medical treatment will be conducted by experienced research personnel at 30 days, 6 months, 1 year and at least 2 years. All site reported deaths, myocardial infarctions and revascularizations will be adjudicated by an independent Clinical Events Committee for all 1000 patients enrolled in the trial. An interim analysis of the first 750 patients will be conducted and data forwarded to FDA.
This study is a prospective study of patients treated at Scripps Clinic with intracoronary brachytherapy for recurrent restenosis within drug eluting stents.
XIENCE V® India is a prospective, open-label, multi-center, observational, single-arm study to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.