Culotte Technique Versus TAP Stunting for the Treatment of de Novo Coronary Bifurcation Lesion With Drug-eluting Stents

NCT01267838 | Completed Phase 4

• 1 other identifier: BBK2 study
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

BBK- 2 - study: STUDY-SUMMARY Background: The need for stenting of the main and side branch (double stenting) in the treatment of coronary bifurcation lesion primarily depends on the complexity of the bifurcation lesion. If the bifurcation lesion is very complex (Medina classification 111, severe stenosis of both branches, severe calcified lesion, long lesions etc.) double stenting may be the treatment of choice. When double stenting is required, the most frequently used stenting techniques are T-stenting and Culotte-stenting. It is still unclear, however, which double stent technique yields the best long-term outcome. Aim: This randomized study will compare the long-term safety and efficacy of T-stenting versus Culotte-stenting in the treatment of de-novo coronary bifurcation lesions with drug-eluting stents. Methods: Three-hundred patients in whom a double-stenting technique is intended for the treatment of a de-novo coronary bifurcation lesion will be randomly assigned to T-stenting or Culotte-stenting with an approved drug-eluting stent. Patients will undergo 9-month angiographic follow-up with quantitative coronary angiography. Clinical follow-up is planed at 30 days, 6 months, 1 year, 2 years, 3 years and 5 years. The primary study endpoint is the maximal percent diameter stenosis in the bifurcation lesion at 9 months. Secondary endpoints include binary restenosis (estimated by Quantitative Coronary Angiography (QCA) analysis), Target Lesion Revascularisation (TLR), Freedom from Major Adverse Cardiac Events (MACE) and the rate of stent thrombosis according to the definition of the Academic Research Consortium (ARC definition). The study will have 90% power to detect a 25% reduction in the primary endpoint at p \< 0.05.

Conditions

Coronary Artery Disease; Restenosis

Keywords

Coronary artery disease; Restenosis; Stent thrombosis

Outcome Measures

Primary Outcomes (1)

• Maximal percent diameter stenosis at the bifurcation (QCA)

  Maximal percent diameter stenosis at the bifurcation (QCA)

  9 months post index PCI

Secondary Outcomes (1)

• TLR of the main and side branch

  12 months post index PCI

Study Arms (2)

T Stenting group

ACTIVE COMPARATOR

PCI of bifurcation lesion with modified T Stenting.

Procedure: PCI

Culotte stenting group

ACTIVE COMPARATOR

PCI of bifurcation lesion with Culotte stenting

Procedure: PCI

Interventions

PCI PROCEDURE

PCI of bifurcation lesions with double stenting

Culotte stenting group; T Stenting group

Eligibility Criteria

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

You may qualify if:

• Clinical indication for interventional treatment of the bifurcation lesion.
• There is indication to perform the double stenting as judged by the operator.
• Bifurcation lesions according to the Medina classification of a native coronary artery with a reference vessel diameter: main branch \>2,5 mm; side branch \>2,25 mm (the difference between vessel diameter of the main and side branch should be ≤1 mm)
• The target lesion (main branch and / or side branch) must be at least 50% diameter stenosis.
• The target lesion has not been previously treated with any interventional procedure.
• The target vessel (main branch and side branch) must be feasible for stent implantation (successful passage with the guide wire; successful predilataion with an appropriately sized balloon; no heavy calcification; no diffuse distal disease that might impede run off).
• Patient has no other treatment planned within 30 days of the procedure.
• Patient has been informed of the nature of the study and agrees to its provisions and has written informed consent as approved by the Ethics Committee.
• Patient is willing to comply all required post-procedure follow-up.

You may not qualify if:

• Patient had an acute myocardial infarction (\> 3x normal CK ) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure.
• Patient will have a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, prasugrel, stainless steel, sirolimus, everolimus, zotarolimus, biolimus or contrast sensitivity that cannot be adequately pre- medicated.
• Non successful treatment of other lesion during the same procedure
• Patient has a platelet count of \<100,000 cells/mm³ or \>700,000 cells/mm³, a White Blood Cells of \<3,000 cells/mm³, or documented or liver disease.
• Patient has a history of bleeding diathesis or coagulopathy.
• Patient has suffered a stroke within the past six months.
• Active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months.
• Patient has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life- expectancy (less than 2 years).
• Indication for oral anticoagulation
• Patient must be excluded from the study if any of these angiographic criteria are met:
• The target vessel contains intraluminal thrombus.
• The target lesion or vessel shows angiographic evidence of severe calcification.
• The patient has undergone previous PCI to the target vessel within 6 months.
• Pre treatment of the lesion is done with a technique other than balloon angioplasty.

Sponsors & Collaborators

• University Heart Center Freiburg - Bad Krozingen: lead

Study Sites (1)

Herz-Zentrum Bad Krozingen

Bad Krozingen, Suedring 15, 79189, Germany

Location

Related Publications (4)

• Ferenc M, Gick M, Kienzle RP, Bestehorn HP, Werner KD, Comberg T, Kuebler P, Buttner HJ, Neumann FJ. Randomized trial on routine vs. provisional T-stenting in the treatment of de novo coronary bifurcation lesions. Eur Heart J. 2008 Dec;29(23):2859-67. doi: 10.1093/eurheartj/ehn455. Epub 2008 Oct 9.

  PMID: 18845665 BACKGROUND

• Adriaenssens T, Byrne RA, Dibra A, Iijima R, Mehilli J, Bruskina O, Schomig A, Kastrati A. Culotte stenting technique in coronary bifurcation disease: angiographic follow-up using dedicated quantitative coronary angiographic analysis and 12-month clinical outcomes. Eur Heart J. 2008 Dec;29(23):2868-76. doi: 10.1093/eurheartj/ehn512. Epub 2008 Nov 11.

  PMID: 19001472 BACKGROUND

• Erglis A, Kumsars I, Niemela M, Kervinen K, Maeng M, Lassen JF, Gunnes P, Stavnes S, Jensen JS, Galloe A, Narbute I, Sondore D, Makikallio T, Ylitalo K, Christiansen EH, Ravkilde J, Steigen TK, Mannsverk J, Thayssen P, Hansen KN, Syvanne M, Helqvist S, Kjell N, Wiseth R, Aaroe J, Puhakka M, Thuesen L; Nordic PCI Study Group. Randomized comparison of coronary bifurcation stenting with the crush versus the culotte technique using sirolimus eluting stents: the Nordic stent technique study. Circ Cardiovasc Interv. 2009 Feb;2(1):27-34. doi: 10.1161/CIRCINTERVENTIONS.108.804658. Epub 2009 Feb 10.

  PMID: 20031690 BACKGROUND

• Hildick-Smith D, de Belder AJ, Cooter N, Curzen NP, Clayton TC, Oldroyd KG, Bennett L, Holmberg S, Cotton JM, Glennon PE, Thomas MR, Maccarthy PA, Baumbach A, Mulvihill NT, Henderson RA, Redwood SR, Starkey IR, Stables RH. Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies. Circulation. 2010 Mar 16;121(10):1235-43. doi: 10.1161/CIRCULATIONAHA.109.888297. Epub 2010 Mar 1.

  PMID: 20194880 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Miroslaw Ferenc, MD

  Herz-Zentrum Bad Krozingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: December 29, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: April 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)