Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon

University Hospital, Saarland2 sites in 1 country90 target enrollmentMarch 1, 2010

ConditionsCoronary De-novo Stenoses

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Coronary De-novo Stenoses
Sponsor: University Hospital, Saarland
Enrollment: 90
Locations: 2
Primary Endpoint: Late lumen loss
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.

Registry

clinicaltrials.gov

Start Date

March 1, 2010

End Date

March 1, 2013

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Saarland

Responsible Party

Principal Investigator

Bruno Scheller

University Hospital, Saarland

Eligibility Criteria

Inclusion Criteria

•Age \> 18 years
•Clinical evidence of stable or unstable angina or a positive functional study
•Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see 4.3.1.1 Definition of lesion types)
•Diameter stenosis \> 70% (visual estimate)
•Vessel diameter 2.5 - 3.5 mm
•Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization
•Signed patient informed consent form
•Patient's and treating physician's agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol

Exclusion Criteria

•Left ventricular ejection fraction of \< 30%
•Visible thrombus proximal to the lesion
•Expection that treatment with devices other than PTCA will be required for this lesion.
•Stenosis is within a bypass graft
•Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated
•Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy, cause the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).
•Acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: Q wave infarction having total creatinine kinase (CK) \>3 times the upper normal limit, or CK remains elevated above hospital normal at time of treatment)
•Chronic renal insufficiency with serum creatinine \> 2.0 mg%
•Significant gastrointestinal (GI) bleed within the past six months.
•History of bleeding diathesis or coagulopathy or will refuse blood transfusions

Outcomes

Primary Outcomes

Late lumen loss

Time Frame: 6 months

Late lumen loss = MLD in-lesion initially - MLD in lesion after six months (after nitroglycerin in identical projections); assessment by an independent Core Lab.