Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments balloon angioplasty, stent implantation
Phase phase 4
Sponsor B.Braun Surgical SA
Collaborator Hospital Universitario Infanta Cristina de Badajoz
Start date June 2010
End date December 2012
Trial size 190 participants
Trial identifier NCT01278186, AAG-G-H-0909

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Paclitaxel-eluting balloon catheter (SeQuent Please, B. Braun)
balloon angioplasty SeQuent Please
Coronary angioplasty using the paclitaxel-coated balloon catheter
(Experimental)
Paclitaxel-eluting stent
stent implantation Paclitaxel-eluting stent
Coronary angioplasty using the paclitaxel-eluting stent

Primary Outcomes

Measure
Late Lumen Loss (LLL)
time frame: Late angiographic follow-up (9 months)
Restenosis
time frame: Late angiographic follow-up (9 months)

Secondary Outcomes

Measure
Thrombosis rate
time frame: Late angiographic follow-up (9 months)
Target Lesion Revascularization (TLR)
time frame: Late angiographic follow-up (9 months)
Major Adverse Cardiac Events (MACE)
time frame: Late angiographic follow-up (9 months)

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Prospective Randomized Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions / BABILON Study (Paclitaxel-Coated Balloon in Bifurcated Lesions)
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by B.Braun Surgical SA.