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

NCT01278186 | Unknown Phase 4

• 1 other identifier: AAG-G-H-0909
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 9

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.

Conditions

Coronary Artery Disease

Keywords

Coronary stenosis; Bifurcation; Drug-eluting balloon; Drug-eluting stent; Angiographic follow-up; Late Lumen Loss; Restenosis

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (3)

• Thrombosis rate

  Late angiographic follow-up (9 months)

• Target Lesion Revascularization (TLR)

  Late angiographic follow-up (9 months)

• Major Adverse Cardiac Events (MACE)

  Late angiographic follow-up (9 months)

Study Arms (2)

Paclitaxel-eluting balloon

EXPERIMENTAL

Paclitaxel-eluting balloon catheter (SeQuent Please, B. Braun)

Procedure: Balloon angioplasty

Paclitaxel-eluting stent

EXPERIMENTAL

Paclitaxel-eluting stent

Procedure: Stent implantation

Interventions

Balloon angioplasty PROCEDURE

Coronary angioplasty using the paclitaxel-coated balloon catheter

Also known as: SeQuent Please

Paclitaxel-eluting balloon

Stent implantation PROCEDURE

Coronary angioplasty using the paclitaxel-eluting stent

Also known as: Paclitaxel-eluting stent

Paclitaxel-eluting stent

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• B.Braun Surgical SA: lead
• Hospital Universitario Infanta Cristina de Badajoz: collaborator

Study Sites (9)

Hospital Universitario Infanta Cristina

Badajoz, Badajoz, 06080, Spain

Location

Hospital Universitari Son Dureta

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Complejo Hospitalario San Pedro de Alcantara

Cáceres, Caceres, 10001, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, Cadiz, 11009, Spain

Location

Hospital Universitario de Puerto Real

Puerto Real, Cadiz, 11510, Spain

Location

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, Malaga, 29010, Spain

Location

Hospital Virgen de la Salud

Toledo, Toledo, 45004, Spain

Location

Related Publications (25)

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• 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. doi: 10.1016/j.jacc.2005.04.054.

  PMID: 16098427 BACKGROUND

• 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. doi: 10.1016/s0735-1097(00)00534-9.

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• 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. doi: 10.1161/01.CIR.0000118474.71662.E3. Epub 2004 Feb 23.

  PMID: 14981005 BACKGROUND

• Pan M, de Lezo JS, Medina A, Romero M, Segura J, Pavlovic D, Delgado A, Ojeda S, Melian F, Herrador J, Urena 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. doi: 10.1016/j.ahj.2004.05.029.

  PMID: 15523318 BACKGROUND

• Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Niemela M, Kervinen K, Jensen JS, Galloe A, Nikus K, Vikman S, Ravkilde J, James S, Aaroe J, Ylitalo A, Helqvist S, Sjogren 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. doi: 10.1161/CIRCULATIONAHA.106.664920. Epub 2006 Oct 23.

  PMID: 17060387 BACKGROUND

• 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

  BACKGROUND

• Pan M, Suarez de Lezo J, Medina A, Romero M, Delgado A, Segura J, Ojeda S, Pavlovic D, Ariza J, Fernandez-Duenas J, Herrador J, Urena 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.

  PMID: 16324581 BACKGROUND

• 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

  BACKGROUND

• Medina A, Suarez de Lezo J, Pan M. [A new classification of coronary bifurcation lesions]. Rev Esp Cardiol. 2006 Feb;59(2):183. No abstract available. Spanish.

  PMID: 16540043 BACKGROUND

• 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. doi: 10.1016/j.ahj.2006.04.033.

  PMID: 16996856 BACKGROUND

• 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. doi: 10.1016/j.jacc.2005.02.086.

  PMID: 15963413 BACKGROUND

• 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. doi: 10.1001/jama.293.17.2126.

  PMID: 15870416 BACKGROUND

• 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. doi: 10.1016/s0735-1097(03)01056-8.

  PMID: 14563585 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.

  PMID: 15302790 BACKGROUND

• Axel DI, Kunert W, Goggelmann C, Oberhoff M, Herdeg C, Kuttner A, Wild DH, Brehm BR, Riessen R, Koveker 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. doi: 10.1161/01.cir.96.2.636.

  PMID: 9244237 BACKGROUND

• Posa A, Hemetsberger R, Petnehazy O, Petrasi Z, Testor M, Glogar D, Gyongyosi 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.

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  BACKGROUND

• 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. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.

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• 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.

  BACKGROUND

• 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.

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• 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.

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• 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.

  BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Jose Ramon Lopez-Minguez, MD, PhD

  Hospital Universitario Infanta Cristina de Badajoz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 17, 2011
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: July 17, 2012

Record last verified: 2012-07

Locations

ES (9)