Treatment of Bifurcated Coronary Lesions With Cypher™-Stent

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by Heart Center Bad Krozingen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cordis, Johnson&Johnson company
Information provided by:
Heart Center Bad Krozingen
ClinicalTrials.gov Identifier:
NCT00288535
First received: February 7, 2006
Last updated: September 17, 2007
Last verified: March 2005
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Procedure: PCI of bifurcated coronary lesions using sirolimus coated stents in modified T-Stenting -Technique
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Single-Center Evaluation of the Cypher™ Sirolimus Eluting Coronary Stent System in the Treatment of Bifurcated Coronary Lesions

Resource links provided by NLM:


Further study details as provided by Heart Center Bad Krozingen:

Primary Outcome Measures:
  • In-segment percent diameter stenosis of the side branch at 9 months post procedure as measured by quantitative coronary angiography.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 200
Study Start Date: March 2005
Estimated Study Completion Date: February 2007
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.

  Eligibility

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

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).
  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: NCT00288535

Contacts
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

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   
Sponsors and Collaborators
Heart Center Bad Krozingen
Cordis, Johnson&Johnson company
Investigators
Principal Investigator: Miroslaw FERENC, Dr. Haert Center Bad Krozingen; Germany
Study Director: Franz-Josef Neumann, Prof. Dr. Heart Center Bad Krozingen, Germany
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00288535     History of Changes
Other Study ID Numbers: HZ-BK-2005-1
Study First Received: February 7, 2006
Last Updated: September 17, 2007
Health Authority: GERMANY: Ethik-Kommision der Albert-Ludwigs-Universitaet Freiburg

Keywords provided by Heart Center Bad Krozingen:
coronary bifurcation ; PCI; modified T-Stenting; sirolimus stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 22, 2014