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Treatment of Bifurcated Coronary Lesions With Cypher™-Stent

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.
 
ClinicalTrials.gov Identifier: NCT00288535
Recruitment Status : Unknown
Verified March 2005 by University Heart Center Freiburg - Bad Krozingen.
Recruitment status was:  Recruiting
First Posted : February 8, 2006
Last Update Posted : September 18, 2007
Sponsor:
Collaborator:
Cordis, Johnson&Johnson company
Information provided by:
University Heart Center Freiburg - Bad Krozingen

Tracking Information
First Submitted Date  ICMJE February 7, 2006
First Posted Date  ICMJE February 8, 2006
Last Update Posted Date September 18, 2007
Study Start Date  ICMJE March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
In-segment percent diameter stenosis of the side branch at 9 months post procedure as measured by quantitative coronary angiography.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2006)
  • Freedom from Major Adverse Cardiac Events (MACE)at 30 days, 6 and 12 months
  • Angiographic binary restenosis (≥ 50% diameter stenosis) in the main and side branch at 9 months post procedure.
  • Target Lesion Revascularization (TLR) at 12 months post procedure.
  • Device success during PCI
  • Post-procedure thrombotic stent occlusion at 12 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Bifurcated Coronary Lesions With Cypher™-Stent
Official Title  ICMJE Prospective, Randomized, Single-Center Evaluation of the Cypher™ Sirolimus Eluting Coronary Stent System in the Treatment of Bifurcated Coronary Lesions
Brief Summary This study is a prospective, randomized, single-center evaluation of the Cypher™ Sirolimus eluting coronary stent system in the treatment of de novo bifurcated coronary lesions comparing provisional modified T stenting with systematic modified T-stenting.
Detailed Description

Bifurcations involving a significant side branch (SB diameter ≥ 2.25 mm) occur in approximately 15-20% of all coronary lesions considered for percutaneous intervention. If a side branch (SB) subtends significant myocardium, failure to preserve SB vessel patency can lead to complications such as myocardial infarction or persistent chest pain despite full patency of the main branch.

Bifurcation lesions are inherently complex and interventional treatment remains a challenging problem for physicians.

The optimal technique for stenting bifurcated lesions is still unknown. Several dual vessel stenting techniques have been described in the literature, such as "T", "V", "Y", "Culotte" and "Crush" procedures. However, most studies of bifurcation stenting have found that optimal long-term results are obtained by stenting the main vessel and then performing plain balloon angioplasty of the side branch ("kissing balloon"-technique). Nevertheless, occlusion or reduced flow of the SB are frequent after stenting of the MB. Therefore, the SB is stented in approximately 50% of procedures even if PTCA alone was intended.

Hypothesis:

Compared with plain dilatation of side branch, the placement of Cypher-Stent in side branch using modified T-stenting technique will reduce "in-segment percent diameter stenosis" of the side branch at 9 months post procedure as measured by quantitative coronary angiography.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Procedure: PCI of bifurcated coronary lesions using sirolimus coated stents in modified T-Stenting -Technique
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 7, 2006)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE February 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. The target vessel must meet the following criteria:

    1. Bifurcated lesion Type 1, 2, 3 or 4 of a native coronary artery with a reference vessel diameter of 2.5 mm to 4.0 mm in the main branch and of ≥ 2.25 mm in the side branch.
    2. The target lesion (main branch and / or side branch) must be at least 50% diameter stenosis.
    3. The target lesion has not been previously treated with any interventional procedure.
    4. The target vessel (main branch and side branch) must be feasible for stent implantation (successful passage with the guide wire; successful predilatation with an appropriately sized balloon; no heavy calcification; no diffuse distal disease that might impede run off).

      2. Patient has stable or unstable angina pectoris (CCS classification I or greater) or a positive stress test for ischemia.

      3. Patient must be ≥ 18 years of age. 4. Female subjects of childbearing potential must have a negative pregnancy test within 7 days before the procedure.

      5. Patient has no other treatment planned within 30 days of the procedure. 6. 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.

      7. Patient willing to comply with required post-procedure follow-up.

      Exclusion Criteria:

  • 1. Patient has had an acute myocardial infarction (> 3x normal CK with presence of CKMB) 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, stainless steel, sirolimus, or contrast sensitivity that cannot be adequately pre-medicated.

    3. Patient has a platelet count of <100,000 cells/mm³ or >700,000 cells/mm³, a WBC of <3,000 cells/mm³, or documented or suspected liver disease.

    4. Patient has a history of bleeding diathesis or coagulopathy. 5. Patient has suffered a CVA or TIA within the past six months. 6. Active peptic ulcer or upper GI bleeding within the prior 6 months. 7. 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).

    8. 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 is located in the left main coronary artery.
    3. The target lesion or vessel shows angiographic evidence of severe calcification.
    4. The patient has undergone previous PCI to the target vessel within 6 months.
    5. Pre treatment of the lesion is done with a technique other than balloon angioplasty (e.g. rotablation).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00288535
Other Study ID Numbers  ICMJE HZ-BK-2005-1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Heart Center Freiburg - Bad Krozingen
Collaborators  ICMJE Cordis, Johnson&Johnson company
Investigators  ICMJE
Principal Investigator: Miroslaw FERENC, Dr. Haert Center Bad Krozingen; Germany
Study Director: Franz-Josef Neumann, Prof. Dr. Heart Center Bad Krozingen, Germany
PRS Account University Heart Center Freiburg - Bad Krozingen
Verification Date March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP