International Randomized Comparison Between DES Limus Carbostent and Taxus DES in the Treatment of De-novo Coronary Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to demonstrate non-inferiority in terms of safety and efficacy of DES Limus Carbostent compared to the Taxus Liberté in treating de-novo atherosclerotic lesions in native coronary arteries.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis

NCT03529006

In-stent Restenosis

UNKNOWN NA

DEB vs Thin-DES in DES-ISR: Long Term Outcomes (DEB Dragon Registry)

NCT04415216

In Stent Restenosis

COMPLETED

XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization

NCT03745053

Coronary Artery Disease

COMPLETED NA

Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion (DECISION-CTO)

NCT01078051

Coronary Artery Disease

TERMINATED PHASE4

Test Safety of Biodegradable and Permanent Limus-Eluting Stents Assessed by Optical Coherence Tomography

NCT01097434

Coronary Heart Disease

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stable Angina Unstable Angina Documented Silent Ischemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DES Limus Carbostent Coronary Stent

Group Type EXPERIMENTAL

DES Limus Carbostent

Intervention Type DEVICE

DES Limus Carbostent Carbofilm Coated Coronary Stent

Taxus Liberté Coronary Stent

Group Type ACTIVE_COMPARATOR

Taxus Liberté Stent

Intervention Type DEVICE

Taxus Liberté Coronary Stent

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DES Limus Carbostent

DES Limus Carbostent Carbofilm Coated Coronary Stent

Intervention Type DEVICE

Taxus Liberté Stent

Taxus Liberté Coronary Stent

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 18 years
* Patient is eligible for percutaneous coronary intervention (PCI) and for surgical revascularization (CABG)
* Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site
* Patients with clinical evidence of ischemic heart disease and/or a positive functional study(e.g. stress test); documented stable (CCS I-IV) or unstable angina pectoris (Braunwald class I-II B and C) or documented silent ischemia
* LVEF\>30%

Exclusion Criteria

* Target lesion should be located in a target vessel with a diameter ranging from 3.0 to 3.75 mm
* Target lesion diameter stenosis \> 50% and \< 100% by visual estimate, with a TIMI flow of ≥ 1
* The target lesion must be appropriately covered (margin of 2.5 mm on both sides of the stent) by one study stent (DES Limus Carbostent or Taxus Liberté, according to the randomization arm). Any occurred dissection of the target vessel must be treated with an additional stent (DES Limus Carbostent or Taxus Liberté, according to the randomization arm)
* Patient that underwent BMS implantation more than 6 months before the enrolment or DES implantation more than 1 year before the enrolment in an other vessel.

* Female with childbearing potential or lactating
* Known sensitivity to sirolimus, paclitaxel, the polymeric matrix, stainless steel or cobalt chromium
* Acute Q-wave or non Q-wave myocardial infarction within 72 hours, or presents with CK elevation greater than 2 times upper limit normal associated with elevated CK-MB
* Cardiogenic shock
* Cerebrovascular accident within the past 6 months
* Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl)
* Contraindication to aspirin or clopidogrel
* Thrombocytopenia (platelet count less than 100,000/mm³)
* Active gastrointestinal bleeding within the past 3 months
* Known bleeding or hypercoagulable disorder
* Prior anaphylactic reaction to contrast agents or contrast sensitivity that cannot be controlled with pre-medication
* Currently under immunosuppressant therapy
* Currently, or has been treated with either Rapamune or paclitaxel within 12 months of the procedure
* Active infection
* Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year;
* Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study
* Patient underwent coronary revascularization to any vessel within 30 days
* Patient underwent target vessel revascularization within 6 months
* Target vessel has had prior stent placement
* Presence of two lesions located in the same vascular territory (same major epicardial vessel)
* Prior coronary brachytherapy
* There is a planned target lesion treatment with any technique other than the pre-dilatation balloon angioplasty
* Treatment of more than two lesions is required at the time of enrolment, or is planned within 30 days following enrolment
* Any planned surgery within 6 months after index procedure
* Left main disease greater than 50% diameter stenosis
* Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off
* Heavily calcified vessel and/or lesion which cannot be successfully predilated
* Target lesion is located or supplied by an arterial or venous bypass graft
* Ostial target lesion or lesion located within 2 mm of a bifurcation
* Target lesion involves a side branch \>2.0 mm in diameter with an ostial disease
* Target lesion has TIMI 0 flow
* Target vessel with angiographically visible thrombus or unsuitable for proper stent delivery and deployment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No