Back to resultsStudy of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions (BABILON)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Balloon angioplasty
Stent implantation
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary stenosis, Bifurcation, Drug-eluting balloon, Drug-eluting stent, Angiographic follow-up, Late Lumen Loss, Restenosis
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
Sites / Locations
- Hospital Universitario de Puerto Real
- Hospital Universitari Son Dureta
- Hospital Universitario Puerta de Hierro Majadahonda
- Hospital Universitario Infanta Cristina
- Complejo Hospitalario San Pedro de Alcantara
- Hospital Universitario Puerta del Mar
- Hospital Clinico San Carlos
- Hospital Universitario Virgen de la Victoria
- Hospital Virgen de la Salud
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Paclitaxel-eluting balloon
Paclitaxel-eluting stent
Arm Description
Paclitaxel-eluting balloon catheter (SeQuent Please, B. Braun)
Paclitaxel-eluting stent
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Thrombosis rate
Assesment of the thrombosis rate
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
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-
Full Information
NCT ID
NCT01278186
First Posted
January 14, 2011
Last Updated
July 16, 2012
Sponsor
B.Braun Surgical SA
Collaborators
Hospital Universitario Infanta Cristina de Badajoz
1. Study Identification
Unique Protocol Identification Number
NCT01278186
Brief Title
Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions
Acronym
BABILON
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
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B.Braun Surgical SA
Collaborators
Hospital Universitario Infanta Cristina de Badajoz
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary stenosis, Bifurcation, Drug-eluting balloon, Drug-eluting stent, Angiographic follow-up, Late Lumen Loss, Restenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel-eluting balloon
Arm Type
Experimental
Arm Description
Paclitaxel-eluting balloon catheter (SeQuent Please, B. Braun)
Arm Title
Paclitaxel-eluting stent
Arm Type
Experimental
Arm Description
Paclitaxel-eluting stent
Intervention Type
Procedure
Intervention Name(s)
Balloon angioplasty
Other Intervention Name(s)
SeQuent Please
Intervention Description
Coronary angioplasty using the paclitaxel-coated balloon catheter
Intervention Type
Procedure
Intervention Name(s)
Stent implantation
Other Intervention Name(s)
Paclitaxel-eluting stent
Intervention Description
Coronary angioplasty using the paclitaxel-eluting stent
Primary Outcome Measure Information:
Title
Late Lumen Loss (LLL)
Description
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
Time Frame
Late angiographic follow-up (9 months)
Title
Restenosis
Description
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
Time Frame
Late angiographic follow-up (9 months)
Secondary Outcome Measure Information:
Title
Thrombosis rate
Description
Assesment of the thrombosis rate
Time Frame
Late angiographic follow-up (9 months)
Title
Target Lesion Revascularization (TLR)
Description
Assessment of the Target Lesion Revascularization (TLR) at late angiographic follow-up (9 months) if dilatation by restenosis or previous angiography due to angina
Time Frame
Late angiographic follow-up (9 months)
Title
Major Adverse Cardiac Events (MACE)
Description
Assessment of the rate of Major Adverse Cardiac Events (MACE): death, AMI, Target Lesion Revascularization (TLR) - due to angina pectoris or angiographic restenosis-
Time Frame
Late angiographic follow-up (9 months)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Ramon Lopez-Minguez, MD, PhD
Organizational Affiliation
Hospital Universitario Infanta Cristina de Badajoz
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitario de Puerto Real
City
Puerto Real
State/Province
Cadiz
ZIP/Postal Code
11510
Country
Spain
Facility Name
Hospital Universitari Son Dureta
City
Palma de Mallorca
State/Province
Illes Balears
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Infanta Cristina
City
Badajoz
ZIP/Postal Code
06080
Country
Spain
Facility Name
Complejo Hospitalario San Pedro de Alcantara
City
Caceres
ZIP/Postal Code
10001
Country
Spain
Facility Name
Hospital Universitario Puerta del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Virgen de la Salud
City
Toledo
ZIP/Postal Code
45004
Country
Spain
12. IPD Sharing Statement
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Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions
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