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

NCT00540813 | Completed

• 1 other identifier: BBM-VS-56
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemia; Stenosis

Keywords

bifurcation stenosis; Patients with documented ischemia due to a de-novo bifurcation stenosis

Outcome Measures

Primary Outcomes (1)

• Procedural success (main branch ≤ 30%, side branch ≤ 50%, TIMI Flow 3)

  acute

Secondary Outcomes (1)

• In-segment late lumen loss at 9 months in either branch

  9 months

Study Arms (1)

Drug Eluting Balloon

EXPERIMENTAL

Device: drug eluting balloon

Interventions

drug eluting balloon DEVICE

drug eluting balloon bifurcated coronary lesions single arm study

Drug Eluting Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• Patient participates in other clinical trials involving any investigational device or drug
• Untreated hyperthyroidism
• Patient has presence or history of severe renal failure (GFR\<30ml/min, "Cockcroft Gault") and is therefore at high risk for angiography associated renal complications. Patient's serum creatinine levels must be documented
• Post transplantation of any organ or immune suppressive medication
• Other disease to jeopardize follow-up (e.g., malignancy)

Sponsors & Collaborators

• Heart Centre Rotenburg: lead
• B. Braun Melsungen AG: collaborator
• Clinical Research Institute Rotenburg a.d.F.: collaborator

Study Sites (2)

F.X.Kleber

Berlin, 12683, Germany

Location

D.G: Mathey

Hamburg, 22527, Germany

Location

MeSH Terms

Conditions

Ischemia; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical

Study Officials

• D. G. Mathey, MD

  Hamburg University Cardiovascular Center GmbH

  PRINCIPAL INVESTIGATOR

• F. X. Kleber, MD

  Department of Internal Medicine Unfallkrankenhaus Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Data Manager

Study Record Dates

• First Submitted: October 5, 2007
• First Posted: October 8, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2011
• Study Completion: October 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

DE (2)