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

Coronary Artery Disease Clinical Trial

— BABILON  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01278186
• Other study ID #: AAG-G-H-0909
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 14, 2011
• Last updated: July 16, 2012
• Start date: June 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2012
• Source: B.Braun Surgical SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Balloon angioplasty
Coronary angioplasty using the paclitaxel-coated balloon catheter
• Stent implantation
Coronary angioplasty using the paclitaxel-eluting stent

Locations

Country	Name	City	State
Spain	Hospital Universitario Infanta Cristina	Badajoz
Spain	Complejo Hospitalario San Pedro de Alcantara	Caceres
Spain	Hospital Universitario Puerta del Mar	Cadiz
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Hospital Universitario Virgen de la Victoria	Malaga
Spain	Hospital Universitari Son Dureta	Palma de Mallorca	Illes Balears
Spain	Hospital Universitario de Puerto Real	Puerto Real	Cadiz
Spain	Hospital Virgen de la Salud	Toledo

Sponsors (2)

Lead Sponsor	Collaborator
B.Braun Surgical SA	Hospital Universitario Infanta Cristina de Badajoz

Country where clinical trial is conducted

Spain, 

References & Publications (25)

Additional Ongoing BRAUN Paclitaxel-Eluting Balloon Clinical Trials in Diabetics,Bifurcations and Chronic Total Occlusions (Other PEPCAD Studies). Mathey DG. Transcatheter Cardiovascular Therapeutics 2008;October 12-17, 2008 • Washington, DC.

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1002/ccd.21452. — View Citation

Ferrerio JL, Cequier A, Gómez JA, Maristany J, Fernández F, Gómez M et al. Contraindicaciones al inicio o interrupción precoz de la doble antiagregación en pacientes con indicación de intervencionismo coronario percutáneo. Rev Esp Cardiol 2007;60 Supl 2:1-192 pag 149.

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

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. — View Citation

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. — View Citation

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. — View Citation

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

Medina A, Suárez de Lezo J, Pan M. [A new classification of coronary bifurcation lesions]. Rev Esp Cardiol. 2006 Feb;59(2):183. Spanish. — View Citation

Nikol S, Huehns TY, Höfling B. Molecular biology and post-angioplasty restenosis. Atherosclerosis. 1996 Jun;123(1-2):17-31. Review. — View Citation

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. — View Citation

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. — View Citation

Pan M, Suárez de Lezo J, Medina A, Romero M, Delgado A, Segura J, Ojeda S, Pavlovic D, Ariza J, Fernández-Dueñas J, Herrador J, Ureña I. [Six-month intravascular ultrasound follow-up of coronary bifurcation lesions treated with rapamycin-eluting stents: technical considerations]. Rev Esp Cardiol. 2005 Nov;58(11):1278-86. Spanish. — View Citation

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. doi: 10.1097/MCA.0b013e3283030b26. — View Citation

Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Böhm 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. — View Citation

Scheller B, Speck U, Abramjuk C, Bernhardt U, Böhm 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. — View Citation

Scheller B, Speck U, Schmitt A, Böhm 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. — View Citation

Scheller B. Drug-Eluting Balloons: The B.BRAUN Paclitaxel-Eluting Balloon Program: Device Characteristics, Experimental Findings, and Clinical. Outcomes in Patients with In-Stent Restenosis and for Small Vessels (PEPCAD I and II). Transcatheter Cardiovascular Therapeutics 2008; Oct 12-17

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. — View Citation

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

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. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8. Erratum in: Circulation. 2008 Oct 14;118(16):e670. — View Citation

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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	Thrombosis rate	Assesment of the thrombosis rate	Late angiographic follow-up (9 months)	Yes
Secondary	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)	Yes
Secondary	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)	Yes