Culotte Technique Versus TAP Stunting for the Treatment of de Novo Coronary Bifurcation Lesion With Drug-eluting Stents (BBK2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01267838
Recruitment Status : Completed
First Posted : December 29, 2010
Last Update Posted : September 7, 2016
Information provided by (Responsible Party):
Dr. Miroslaw FERENC, Heart Center Bad Krozingen

Brief Summary:

BBK- 2 - study:



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.


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.


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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Restenosis Procedure: PCI Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Comparison of T-stenting Versus Culotte Technique for the Treatment of de Novo Coronary Bifurcation Lesion With Drug-eluting Stents.
Study Start Date : February 2010
Actual Primary Completion Date : February 2015
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Active Comparator: T Stenting group
PCI of bifurcation lesion with modified T Stenting.
Procedure: PCI
PCI of bifurcation lesions with double stenting

Active Comparator: Culotte stenting group
PCI of bifurcation lesion with Culotte stenting
Procedure: PCI
PCI of bifurcation lesions with double stenting

Primary Outcome Measures :
  1. Maximal percent diameter stenosis at the bifurcation (QCA) [ Time Frame: 9 months post index PCI ]
    Maximal percent diameter stenosis at the bifurcation (QCA)

Secondary Outcome Measures :
  1. TLR of the main and side branch [ Time Frame: 12 months post index PCI ]
    TLR of the main and side branch at 12 months post procedure

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Clinical indication for interventional treatment of the bifurcation lesion.
  2. There is indication to perform the double stenting as judged by the operator.
  3. 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)

  4. The target lesion (main branch and / or side branch) must be at least 50% diameter stenosis.
  5. The target lesion has not been previously treated with any interventional procedure.
  6. 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).
  7. Patient has no other treatment planned within 30 days of the procedure.
  8. 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.
  9. Patient is willing to comply all required post-procedure follow-up.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Non successful treatment of other lesion during the same procedure
  4. 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.
  5. Patient has a history of bleeding diathesis or coagulopathy.
  6. Patient has suffered a stroke within the past six months.
  7. Active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months.
  8. 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).
  9. Indication for oral anticoagulation
  10. Patient must be excluded from the study if any of these angiographic criteria are met:

    1. The target vessel contains intraluminal thrombus.
    2. The target lesion or vessel shows angiographic evidence of severe calcification.
    3. The patient has undergone previous PCI to the target vessel within 6 months.
    4. Pre treatment of the lesion is done with a technique other than balloon angioplasty.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01267838

Herz-Zentrum Bad Krozingen
Bad Krozingen, Suedring 15, Germany, 79189
Sponsors and Collaborators
Heart Center Bad Krozingen
Principal Investigator: Miroslaw Ferenc, MD Herz-Zentrum Bad Krozingen


Responsible Party: Dr. Miroslaw FERENC, MD, Heart Center Bad Krozingen Identifier: NCT01267838     History of Changes
Other Study ID Numbers: BBK2 study
First Posted: December 29, 2010    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Dr. Miroslaw FERENC, Heart Center Bad Krozingen:
Coronary artery disease
Stent thrombosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases