search
Back to results

Treatment of Bifurcated Coronary Lesions With Cypher™-Stent

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
PCI of bifurcated coronary lesions using sirolimus coated stents in modified T-Stenting -Technique
Sponsored by
University Heart Center Freiburg - Bad Krozingen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary bifurcation ; PCI; modified T-Stenting; sirolimus stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. The target vessel must meet the following criteria: 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. 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 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: The target vessel contains intraluminal thrombus. The target lesion is located in the left main coronary artery. 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 (e.g. rotablation).

Sites / Locations

  • Herz-Zentrum Bad KrozingenRecruiting

Outcomes

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

Full Information

First Posted
February 7, 2006
Last Updated
September 17, 2007
Sponsor
University Heart Center Freiburg - Bad Krozingen
Collaborators
Cordis, Johnson&Johnson company
search

1. Study Identification

Unique Protocol Identification Number
NCT00288535
Brief Title
Treatment of Bifurcated Coronary Lesions With Cypher™-Stent
Official Title
Prospective, Randomized, Single-Center Evaluation of the Cypher™ Sirolimus Eluting Coronary Stent System in the Treatment of Bifurcated Coronary Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Heart Center Freiburg - Bad Krozingen
Collaborators
Cordis, Johnson&Johnson company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary bifurcation ; PCI; modified T-Stenting; sirolimus stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
PCI of bifurcated coronary lesions using sirolimus coated stents in modified T-Stenting -Technique
Primary Outcome Measure Information:
Title
In-segment percent diameter stenosis of the side branch at 9 months post procedure as measured by quantitative coronary angiography.
Secondary Outcome Measure Information:
Title
Freedom from Major Adverse Cardiac Events (MACE)at 30 days, 6 and 12 months
Title
Angiographic binary restenosis (≥ 50% diameter stenosis) in the main and side branch at 9 months post procedure.
Title
Target Lesion Revascularization (TLR) at 12 months post procedure.
Title
Device success during PCI
Title
Post-procedure thrombotic stent occlusion at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. The target vessel must meet the following criteria: 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. 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 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: The target vessel contains intraluminal thrombus. The target lesion is located in the left main coronary artery. 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 (e.g. rotablation).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miroslaw Ferenc, Dr.
Phone
0049 7633 4020
Email
Miroslaw.Ferenc@herzzentrum.de
First Name & Middle Initial & Last Name or Official Title & Degree
Franz-Josef Neumann, Prof. Dr.
Phone
0049 7633 4020
Email
Franz-Josef.Neumann@herzzentrum.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miroslaw FERENC, Dr.
Organizational Affiliation
Haert Center Bad Krozingen; Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Franz-Josef Neumann, Prof. Dr.
Organizational Affiliation
Heart Center Bad Krozingen, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Herz-Zentrum Bad Krozingen
City
Bad Krozingen
State/Province
Suedring 15
ZIP/Postal Code
79189
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miroslaw Ferenc, Dr.
Phone
0049 7633 4020
Email
Miroslaw.Ferenc@herzzentrum.de
First Name & Middle Initial & Last Name & Degree
Franz-Josef Neumann, Prof. Dr.
Phone
0049 7633 4020
Email
Franz-Josef.Neumann@herzzentrum.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
14981005
Citation
Colombo A, Moses JW, Morice MC, Ludwig J, Holmes DR Jr, Spanos V, Louvard Y, Desmedt B, Di Mario C, Leon MB. Randomized study to evaluate sirolimus-eluting stents implanted at coronary bifurcation lesions. Circulation. 2004 Mar 16;109(10):1244-9. doi: 10.1161/01.CIR.0000118474.71662.E3. Epub 2004 Feb 23.
Results Reference
background
PubMed Identifier
10700058
Citation
Lefevre T, Louvard Y, Morice MC, Dumas P, Loubeyre C, Benslimane A, Premchand RK, Guillard N, Piechaud JF. Stenting of bifurcation lesions: classification, treatments, and results. Catheter Cardiovasc Interv. 2000 Mar;49(3):274-83. doi: 10.1002/(sici)1522-726x(200003)49:33.0.co;2-n.
Results Reference
background
PubMed Identifier
11356386
Citation
Al Suwaidi J, Yeh W, Cohen HA, Detre KM, Williams DO, Holmes DR Jr. Immediate and one-year outcome in patients with coronary bifurcation lesions in the modern era (NHLBI dynamic registry). Am J Cardiol. 2001 May 15;87(10):1139-44. doi: 10.1016/s0002-9149(01)01482-5.
Results Reference
background
Citation
Holmes DR, Leon MB, Moses JW et al. One-year follow-up of the SIRIUS study : a randomized study with the sirolimus-eluting Bx Velocity in the treatment of patients with denovo native coronary artery lesions. J Am Coll Cardiol 2003;41:32A
Results Reference
background
PubMed Identifier
10758954
Citation
Yamashita T, Nishida T, Adamian MG, Briguori C, Vaghetti M, Corvaja N, Albiero R, Finci L, Di Mario C, Tobis JM, Colombo A. Bifurcation lesions: two stents versus one stent--immediate and follow-up results. J Am Coll Cardiol. 2000 Apr;35(5):1145-51. doi: 10.1016/s0735-1097(00)00534-9.
Results Reference
background
PubMed Identifier
26696453
Citation
Ferenc M, Ayoub M, Buttner HJ, Gick M, Comberg T, Rothe J, Valina CM, Hochholzer W, Neumann FJ. Long-term outcomes of routine versus provisional T-stenting for de novo coronary bifurcation lesions: five-year results of the Bifurcations Bad Krozingen I study. EuroIntervention. 2015 Dec;11(8):856-9. doi: 10.4244/EIJV11I8A175.
Results Reference
derived
PubMed Identifier
18845665
Citation
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.
Results Reference
derived

Learn more about this trial

Treatment of Bifurcated Coronary Lesions With Cypher™-Stent

We'll reach out to this number within 24 hrs