Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions (BABILON)

July 16, 2012 updated by: B.Braun Surgical SA

Prospective Randomized Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions / BABILON Study (Paclitaxel-Coated Balloon in Bifurcated Lesions)

This study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of "provisional stenting" with the paclitaxel-eluting stent in the main branch.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The bifurcated coronary lesions are still a challenge for interventional cardiologists, since there is no suitable technique or strategy to manage such lesions.

This multicenter randomized prospective trial in bifurcated coronary lesions will compare the new technology of the paclitaxel-eluting balloon with the until now "gold standard" technique of the "provisional stenting" with the paclitaxel DES in the main branch.

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain, 06080
        • Hospital Universitario Infanta Cristina
      • Caceres, Spain, 10001
        • Complejo Hospitalario San Pedro de Alcantara
      • Cadiz, Spain, 11009
        • Hospital Universitario Puerta Del Mar
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Malaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Toledo, Spain, 45004
        • Hospital Virgen De La Salud
    • Cadiz
      • Puerto Real, Cadiz, Spain, 11510
        • Hospital Universitario de Puerto Real
    • Illes Balears
      • Palma de Mallorca, Illes Balears, Spain, 07014
        • Hospital Universitari Son Dureta
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro Majadahonda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

PATIENTS

  • Patients with stable angina (1-3) or unstable angina (1-3 A-C) or documented silent ischemia
  • Patients with mental and logistic conditions for the follow-up
  • Patients should accept an angiographic follow-up at 9 months, a clinical follow-up at 3 years and sign the consent

LESIONS

  • De-novo lesions in the bifurcations of DA/Diag either CX/OM or CD/DP with diameters in the main vessel of 2,5 to 3,8/ 2 to 3,5 and lengths < 22 mm
  • The left main lesions in bifurcation are also accepted but with another independent randomization list (specify at randomization)
  • The diameter of the stenoses should be >50% in any branch with documented ischemia or more than 70% in absence of an ischemia test
  • Single vessel or multivessel disease
  • In case of a PTCA of more than one lesion, the non included lesion should be treated previously to the included lesion

Exclusion Criteria:

PATIENTS

  • Patients with STEMI < 72 hours
  • Patients with congestive heart failure or NYHA IV, shock or severe valvular heart disease
  • Patients with short life expectancy, or with problems for platelet antiaggregation
  • Patients in treatment with hyperthyroidism, in treatment with immunosuppression or anticoagulants, or with alcohol or drug addiction
  • Patients included in other trials
  • Patients with a stroke 6 months before
  • Patients with a surgery one week before
  • Severe renal failure calculated as GF < 30 ml/min "Cockcroft Gault"
  • Women of childbearing age, with probability to become pregnant during the first year of follow-up

LESIONS

  • Evidence of important thrombus within the vessel to treat
  • Patients with another stent previously implanted at ≤ 15 mm from the current lesion of the study
  • Lesions affecting bypass
  • Chronic occlusions to treat
  • Restenosis in-stent or of a segment in 4 mm close to the target lesion
  • Severe calcification not totally dilatable with the balloon

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Paclitaxel-eluting balloon
Paclitaxel-eluting balloon catheter (SeQuent Please, B. Braun)
Procedure: Balloon angioplasty
Coronary angioplasty using the paclitaxel-coated balloon catheter
Other Names:
  • SeQuent Please
EXPERIMENTAL: Paclitaxel-eluting stent
Procedure: Stent implantation
Coronary angioplasty using the paclitaxel-eluting stent
Other Names:
  • Paclitaxel-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late Lumen Loss (LLL)
Time Frame: Late angiographic follow-up (9 months)
Assessment of the difference between both groups regarding the Late Lumen Loss (LLL) in main vessel and side branch, measured at late angiographic follow-up at 9 months
Late angiographic follow-up (9 months)
Restenosis
Time Frame: Late angiographic follow-up (9 months)
Assessment of the difference between both groups regarding the Restenosis in both branches (proximal part of the main vessel, distal part of the main vessel and side branch), measured at late angiographic follow-up at 9 months
Late angiographic follow-up (9 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thrombosis rate
Time Frame: Late angiographic follow-up (9 months)
Assesment of the thrombosis rate
Late angiographic follow-up (9 months)
Target Lesion Revascularization (TLR)
Time Frame: Late angiographic follow-up (9 months)
Assessment of the Target Lesion Revascularization (TLR) at late angiographic follow-up (9 months) if dilatation by restenosis or previous angiography due to angina
Late angiographic follow-up (9 months)
Major Adverse Cardiac Events (MACE)
Time Frame: Late angiographic follow-up (9 months)
Assessment of the rate of Major Adverse Cardiac Events (MACE): death, AMI, Target Lesion Revascularization (TLR) - due to angina pectoris or angiographic restenosis-
Late angiographic follow-up (9 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B.Braun Surgical SA

Collaborators

Hospital Universitario Infanta Cristina de Badajoz

Investigators

  • Study Director: Jose Ramon Lopez-Minguez, MD, PhD, Hospital Universitario Infanta Cristina de Badajoz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (ESTIMATE)

January 17, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-G-H-0909

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Balloon angioplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe