Randomised Comparison of T-stenting Versus Culotte Technique for the Treatment of de Novo Coronary Bifurcation Lesion With Drug-eluting Stents (BBK2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Heart Center Bad Krozingen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Heart Center Bad Krozingen
ClinicalTrials.gov Identifier:
NCT01267838
First received: December 28, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Restenosis
Stent Thrombosis
Procedure: PCI
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Heart Center Bad Krozingen:

Primary Outcome Measures:
  • Maximal percent diameter stenosis at the bifurcation (QCA) [ Time Frame: 9 months post index PCI ] [ Designated as safety issue: Yes ]
    Maximal percent diameter stenosis at the bifurcation (QCA)


Secondary Outcome Measures:
  • TLR of the main and side branch [ Time Frame: 12 months post index PCI ] [ Designated as safety issue: Yes ]
    TLR of the main and side branch at 12 months post procedure


Estimated Enrollment: 300
Study Start Date: February 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267838

Locations
Germany
Herz-Zentrum Bad Krozingen Recruiting
Bad Krozingen, Suedring 15, Germany, 79189
Contact: Miroslaw Ferenc, Dr.    0049 7633 4020    Miroslaw.Ferenc@herzzentrum.de   
Contact: Franz-Josef Neumann, Prof. Dr.    0049 7633 4020    Franz-Josef.Neumann@herzzentrum.de   
Principal Investigator: Miroslaw Ferenc, MD         
Sponsors and Collaborators
Heart Center Bad Krozingen
Investigators
Principal Investigator: Miroslaw Ferenc, MD Herz-Zentrum Bad Krozingen
  More Information

Publications:

Responsible Party: Dr FERENC Miroslaw MD, Heart Center Bad Krozingen
ClinicalTrials.gov Identifier: NCT01267838     History of Changes
Other Study ID Numbers: BBK2 study
Study First Received: December 28, 2010
Last Updated: December 28, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Heart Center Bad Krozingen:
Coronary artery disease
Restenosis
Stent thrombosis

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

ClinicalTrials.gov processed this record on August 18, 2014