Clinical trial NCT01278186: Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions
Official title: Prospective Randomized Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions / BABILON Study (Paclitaxel-Coated Balloon in Bifurcated Lesions)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary stenosis
Bifurcation
Drug-eluting balloon
Drug-eluting stent
Angiographic follow-up
Late Lumen Loss
Restenosis
Lead sponsor: B.Braun Surgical SA
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario Infanta Cristina de Badajoz
First posted: 2011-01-17
Enrollment: 190
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Late Lumen Loss (LLL)
timeFrame: Late angiographic follow-up (9 months)
measure: Restenosis
timeFrame: Late angiographic follow-up (9 months)
Secondary outcomes:
measure: Thrombosis rate
timeFrame: Late angiographic follow-up (9 months)
measure: Target Lesion Revascularization (TLR)
timeFrame: Late angiographic follow-up (9 months)
measure: Major Adverse Cardiac Events (MACE)
timeFrame: Late angiographic follow-up (9 months)
Other outcomes:
Locations:
city: Puerto Real
country: Spain
facility: Hospital Universitario de Puerto Real
state: Cadiz
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Dureta
state: Illes Balears
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Badajoz
country: Spain
facility: Hospital Universitario Infanta Cristina
city: Caceres
country: Spain
facility: Complejo Hospitalario San Pedro de Alcantara
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
Study officials:
affiliation: Hospital Universitario Infanta Cristina de Badajoz
name: Jose Ramon Lopez-Minguez, MD, PhD
role: STUDY_DIRECTOR
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