Paclitaxel-Eluting Balloon Angioplasty and Coroflex™-Stents in the Treatment of Bifurcated Coronary Lesions

Heart Centre Rotenburg2 sites in 1 country28 target enrollmentOctober 2007

ConditionsIschemia Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ischemia
Sponsor: Heart Centre Rotenburg
Enrollment: 28
Locations: 2
Primary Endpoint: Procedural success (main branch ≤ 30%, side branch ≤ 50%, TIMI Flow 3)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to investigate the feasibility of Paclitaxel-eluting PTCA-balloon dilation (SeQuent Please) followed by bare metal stent (Coroflex ) deployment in the main branch (reference diameter: ≥ 2.5 mm and ≤ 3.8 mm, reference diameter of side branch: ≥ 2.0 mm and ≤ 3.5 mm, length of stenoses in either branch ≤ 20 mm) in the treatment of significant (>70%) de-novo-bifurcation stenoses of any Medina classification type in the native left coronary artery as reflected by procedural success and to evaluate the preservation of vessel patency.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

October 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Heart Centre Rotenburg

Responsible Party

Principal Investigator

Ralf Degenhardt, PhD

Data Manager

Heart Centre Rotenburg

Eligibility Criteria

Inclusion Criteria

•Patients with stable angina pectoris (CCS class 1-3) or with unstable angina pectoris (Braunwald class 1-2, A-C) or documented ischemia or with documented silent ischemia
•Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 6-month follow-up
•Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
•Patients must agree to undergo the 9-month angiographic follow-up
•Patients must agree to undergo the 3-year clinical follow-up
•Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives of this trial. The patients, by providing their informed consent, must agree to these risks and benefits as stated in the patient informed consent document.
•Inclusion Criteria: Lesion Related
•De-novo bifurcational native left coronary artery lesion (reference diameter LAD or LCx: 2.5 mm to 3.8 mm, length of stenosis: ≤ 20 mm, reference diameter D1/D2 or OMS1/OMS2: 2.0 mm to 3.5 mm, length of stenosis: ≤ 20 mm)
•Diameter stenosis pre procedure must be either more then 70 % in either one or both branches of the lesion (i.e., bifurcational lesion of any type of the Medina classification) or more then 50 % if ischemia corresponding to the target lesion is documented either by exercise stress ECG, stress echocardiography, scintigraphy, MRT, or suspected based on angina pectoris
•Single or multi-vessel coronary artery disease

Exclusion Criteria

•Patients with acute (\< 24 h) or recent (48 hours) myocardial infarction
•Patients with unstable angina pectoris (Braunwald class 3)
•Patients with severe congestive heart failure
•Patients with severe heart failure NYHA IV
•Patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mmHg requiring inotropic support, IABP, and/or fluid challenge)
•Patients with severe valvular heart disease
•Women who are pregnant or lactating
•Patients with life expectancy of less than five years or factors making clinical follow-up difficult
•Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
•Patients who had a cerebral stroke \< 6 months prior to the procedure