Treatment of Bifurcated Coronary Lesions With Cypher™-Stent

NCT00288535 | Unknown Phase 4

• 1 other identifier: HZ-BK-2005-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

coronary bifurcation ; PCI; modified T-Stenting; sirolimus stent

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

• 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

Interventions

PCI of bifurcated coronary lesions using sirolimus coated stents in modified T-Stenting -Technique PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).
• \. Patient has stable or unstable angina pectoris (CCS classification I or greater) or a positive stress test for ischemia.
• \. 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.
• \. 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.
• \. Patient willing to comply with required post-procedure follow-up.

You may not qualify if:

• \. 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.
• \. Patient will have a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel, sirolimus, or contrast sensitivity that cannot be adequately pre-medicated.
• \. 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.
• \. 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).
• \. 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).

Sponsors & Collaborators

• University Heart Center Freiburg - Bad Krozingen: lead
• Cordis, Johnson&Johnson company: collaborator

Study Sites (1)

Herz-Zentrum Bad Krozingen

Bad Krozingen, Suedring 15, 79189, Germany

RECRUITING

Related Publications (7)

• 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.

  PMID: 14981005 BACKGROUND

• 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.

  PMID: 10700058 BACKGROUND

• 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.

  PMID: 11356386 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 10758954 BACKGROUND

• 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.

  PMID: 26696453 DERIVED

• 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.

  PMID: 18845665 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Miroslaw FERENC, Dr.

  Haert Center Bad Krozingen; Germany

  PRINCIPAL INVESTIGATOR

• Franz-Josef Neumann, Prof. Dr.

  Heart Center Bad Krozingen, Germany

  STUDY DIRECTOR

Central Study Contacts

Miroslaw Ferenc, Dr.

CONTACT

0049 7633 4020; Miroslaw.Ferenc@herzzentrum.de

Franz-Josef Neumann, Prof. Dr.

CONTACT

0049 7633 4020; Franz-Josef.Neumann@herzzentrum.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 8, 2006
• Study Start: March 1, 2005
• Study Completion: February 1, 2007
• Last Updated: September 18, 2007

Record last verified: 2005-03

Locations

DE (1)