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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Balloon angioplasty
* Procedure: Stent implantation


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel-eluting balloon<br>Paclitaxel-eluting balloon catheter (SeQuent Please, B. Braun) | Procedure: Balloon angioplasty<br>* Coronary angioplasty using the paclitaxel-coated balloon catheter<br>* Other names: SeQuent Please;|
| Experimental: Paclitaxel-eluting stent<br>Paclitaxel-eluting stent | Procedure: Stent implantation<br>* Coronary angioplasty using the paclitaxel-eluting stent<br>* Other names: Paclitaxel-eluting stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Lumen Loss (LLL) | 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 | 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 | Assesment of the thrombosis rate | Late angiographic follow-up (9 months) | 
| Target Lesion Revascularization (TLR) | 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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary stenosis, Bifurcation, Drug-eluting balloon, Drug-eluting stent, Angiographic follow-up, Late Lumen Loss, Restenosis