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

B. Braun

Status and phase

Unknown

Phase 4

Conditions

Coronary Artery Disease

Treatments

Procedure: Stent implantation

Procedure: Balloon angioplasty

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01278186

AAG-G-H-0909

Details and patient eligibility

About

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.

Full 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.

Enrollment

190 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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