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

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:

MedlinePlus related topics: Angioplasty Coronary Artery Disease

Drug Information available for: Paclitaxel

U.S. FDA Resources

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

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:

Iakovou I, Ge L, Colombo A. Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. Epub 2005 Sep 28. Review.

Lefevre T, Louvard Y, Morice MC, Dumas P, Loubeyre C, Benslimane A, Premchand RK, Guillard N, Piechaud JF. Stenting of bifurcation lesions: classification, treatments, and results. Catheter Cardiovasc Interv. 2000 Mar;49(3):274-83.

Koo BK, Kang HJ, Youn TJ, Chae IH, Choi DJ, Kim HS, Sohn DW, Oh BH, Lee MM, Park YB, Choi YS, Tahk SJ. Physiologic assessment of jailed side branch lesions using fractional flow reserve. J Am Coll Cardiol. 2005 Aug 16;46(4):633-7.

Yamashita T, Nishida T, Adamian MG, Briguori C, Vaghetti M, Corvaja N, Albiero R, Finci L, Di Mario C, Tobis JM, Colombo A. Bifurcation lesions: two stents versus one stent--immediate and follow-up results. J Am Coll Cardiol. 2000 Apr;35(5):1145-51.

Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR Jr, Spanos V, Louvard Y, Desmedt B, Di Mario C, Leon MB. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation. 2004 Mar 16;109(10):1244-9. Epub 2004 Feb 23.

Pan M, de Lezo JS, Medina A, Romero M, Segura J, Pavlovic D, Delgado A, Ojeda S, Melián F, Herrador J, Ureña I, Burgos L. Rapamycin-eluting stents for the treatment of bifurcated coronary lesions: a randomized comparison of a simple versus complex strategy. Am Heart J. 2004 Nov;148(5):857-64.

Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Niemelä M, Kervinen K, Jensen JS, Galløe A, Nikus K, Vikman S, Ravkilde J, James S, Aarøe J, Ylitalo A, Helqvist S, Sjögren I, Thayssen P, Virtanen K, Puhakka M, Airaksinen J, Lassen JF, Thuesen L; Nordic PCI Study Group. Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation. 2006 Oct 31;114(18):1955-61. Epub 2006 Oct 23.

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

Dzavik V, Kharbanda R, Ivanov J, Ing DJ, Bui S, Mackie K, Ramsamujh R, Barolet A, Schwartz L, Seidelin PH. Predictors of long-term outcome after crush stenting of coronary bifurcation lesions: importance of the bifurcation angle. Am Heart J. 2006 Oct;152(4):762-9.

Ong AT, McFadden EP, Regar E, de Jaegere PP, van Domburg RT, Serruys PW. Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol. 2005 Jun 21;45(12):2088-92.

Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30.

Scheller B, Speck U, Schmitt A, Bohm M, Nickenig G. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003 Oct 15;42(8):1415-20.

Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. Epub 2004 Aug 9.

Axel DI, Kunert W, Göggelmann C, Oberhoff M, Herdeg C, Küttner A, Wild DH, Brehm BR, Riessen R, Köveker G, Karsch KR. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation. 1997 Jul 15;96(2):636-45.

Posa A, Hemetsberger R, Petnehazy O, Petrasi Z, Testor M, Glogar D, Gyöngyösi M. Attainment of local drug delivery with paclitaxel-eluting balloon in porcine coronary arteries. Coron Artery Dis. 2008 Jun;19(4):243-7.

Nikol S, Huehns TY, Höfling B. Molecular biology and post-angioplasty restenosis. Atherosclerosis. 1996 Jun;123(1-2):17-31. Review. No abstract available.

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. Epub 2006 Nov 13.

Fanggiday JC, Stella PR, Guyomi SH, Doevendans PA. Safety and efficacy of drug-eluting balloons in percutaneous treatment of bifurcation lesions: the DEBIUT (drug-eluting balloon in bifurcation Utrecht) registry. Catheter Cardiovasc Interv. 2008 Apr 1;71(5):629-35.

Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. Epub 2008 Sep 8.

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 May 16, 2013

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