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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by B.Braun Surgical SA.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hospital Universitario Infanta Cristina de Badajoz
Information provided by (Responsible Party):
B.Braun Surgical SA
ClinicalTrials.gov Identifier:
NCT01278186
First received: January 14, 2011
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Procedure: Balloon angioplasty
Procedure: Stent implantation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions / BABILON Study (Paclitaxel-Coated Balloon in Bifurcated Lesions)

Resource links provided by NLM:


Further study details as provided by B.Braun Surgical SA:

Primary Outcome Measures:
  • Late Lumen Loss (LLL) [ Time Frame: Late angiographic follow-up (9 months) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Late angiographic follow-up (9 months) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Late angiographic follow-up (9 months) ] [ Designated as safety issue: Yes ]
    Assesment of the thrombosis rate

  • Target Lesion Revascularization (TLR) [ Time Frame: Late angiographic follow-up (9 months) ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Late angiographic follow-up (9 months) ] [ Designated as safety issue: Yes ]
    Assessment of the rate of Major Adverse Cardiac Events (MACE): death, AMI, Target Lesion Revascularization (TLR) - due to angina pectoris or angiographic restenosis-


Estimated Enrollment: 190
Study Start Date: June 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paclitaxel-eluting balloon
Paclitaxel-eluting balloon catheter (SeQuent Please, B. Braun)
Procedure: Balloon angioplasty
Coronary angioplasty using the paclitaxel-coated balloon catheter
Other Name: SeQuent Please
Experimental: Paclitaxel-eluting stent
Paclitaxel-eluting stent
Procedure: Stent implantation
Coronary angioplasty using the paclitaxel-eluting stent
Other Name: Paclitaxel-eluting stent

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278186

Locations
Spain
Hospital Universitario de Puerto Real
Puerto Real, Cadiz, Spain, 11510
Hospital Universitari Son Dureta
Palma de Mallorca, Illes Balears, Spain, 07014
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain, 28222
Hospital Universitario Infanta Cristina
Badajoz, Spain, 06080
Complejo Hospitalario San Pedro de Alcantara
Caceres, Spain, 10001
Hospital Universitario Puerta del Mar
Cadiz, Spain, 11009
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario Virgen de la Victoria
Malaga, Spain, 29010
Hospital Virgen de la Salud
Toledo, Spain, 45004
Sponsors and Collaborators
B.Braun Surgical SA
Hospital Universitario Infanta Cristina de Badajoz
Investigators
Study Director: Jose Ramon Lopez-Minguez, MD, PhD Hospital Universitario Infanta Cristina de Badajoz
  More Information

Publications:
Hildick-Smith D, The BBC ONE (British Bifurcation Coronary study: Old, New and Evolving strategies). Transcatheter Cardiovascular Therapeutics 2008; Oct 12-17. 2008. Washington DC. TCT 2008
Suárez de Lezo J, Medina A, Martín P, Amador C, Delgado A, Suárez de Lezo J et al. Hallazgos ultrasónicos durante el tratamiento percutáneo de lesiones coronarias en bifurcaciones. Rev Esp Cardiol 2008;61:930-5
Medina A, Suarez de Lezo J, Pan M. Una clasificación simple de las lesiones coronarias en bifurcación. Rev Esp Cardiol. 2006;29:183

Responsible Party: B.Braun Surgical SA
ClinicalTrials.gov Identifier: NCT01278186     History of Changes
Other Study ID Numbers: AAG-G-H-0909
Study First Received: January 14, 2011
Last Updated: July 16, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by B.Braun Surgical SA:
Coronary stenosis
Bifurcation
Drug-eluting balloon
Drug-eluting stent
Angiographic follow-up
Late Lumen Loss
Restenosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014