The Study of the Crushing Technique Application Using SES in Coronary Bifurcations.

NCT00749424 | Completed Phase 4 DMC

• 1 other identifier: CRDIT 00-01/03
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the safety and effectiveness of two different approaches to treat bifurcational lesions with CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent , Cordis Corp): a) the "crushing" technique to stent both branches vs. b) a provisional T stenting technique of the side branch.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Major Adverse and Cardiac Events (MACE)

  6 and 12 months post-procedure

Secondary Outcomes (2)

• Minimal lumen diameter (MLD)

  6 months

• Percent diameter stenosis (%DS)

  6 months

Study Arms (2)

1

EXPERIMENTAL

crushing technique

Device: SES

2

ACTIVE COMPARATOR

provisional T stenting technique

Device: SES

Interventions

SES DEVICE

CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent

1

Eligibility Criteria

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

You may qualify if:

• Is a male or non-pregnant female patient \>= 18 years of age \[NOTE: Females of child-bearing potential must have a negative pregnancy test\];
• Has a diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR has documented silent ischemia;
• Has at least TIMI I coronary flow in both the main and side branches;
• Involves a single treatment of a de novo bifurcation lesion in native coronary arteries of patients with single or multivessel disease; patients with multiple lesions can be included only if other lesions treated during the index procedure are successfully treated prior to the treatment of the bifurcation lesion;
• Has a true bifurcation lesion defined as stenosis \> 50% in both the main branch and the ostium of the side branch;
• Has a maximum treatable main or side branch lesion length \<=28 mm;
• Has a main branch vessel that is \>= 2.5 mm and \<= 3.5 mm in diameter by on-line QCA proximal to the bifurcation;
• Has a side branch vessel that is \>= 2.25 mm and \<= 3.5 mm in diameter by on-line QCA;
• Is an acceptable candidate for coronary artery bypass surgery (CABG);
• Is willing to comply with the specified follow-up evaluation;
• The patient or legally authorized representative must provide written informed consent prior to the procedure.

You may not qualify if:

• Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented elevation of CK levels \> 2 times normal or CK-MB levels \> 3 times normal within the preceding 24 hours and/or the CK and CK-MB enzymes remain above normal at the time of treatment;
• Has unstable angina classified as Braunwald A I-III, B\&C III;
• Has a bifurcation lesion in a non protected left main;
• Has an ejection fraction \<= 35%;
• Has known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or sirolimus;
• Has a known serious allergy to contrast media or stainless steel that cannot be managed medically;
• Has impaired renal function (creatinine \> 3.0 mg/dl);
• There is presence of thrombus in the bifurcation lesion;
• Has a target lesion with excessive tortuousity unsuitable for stent delivery and deployment;
• Has a totally occluded vessel;
• Is the recipient of a heart transplant;
• Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
• Is currently participating in an investigational drug or another device study.

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Fondazione Centro San Raffaele del Monte Tabor

Milan, 20132, Italy

Location

Related Publications (1)

• Colombo A, Bramucci E, Sacca S, Violini R, Lettieri C, Zanini R, Sheiban I, Paloscia L, Grube E, Schofer J, Bolognese L, Orlandi M, Niccoli G, Latib A, Airoldi F. Randomized study of the crush technique versus provisional side-branch stenting in true coronary bifurcations: the CACTUS (Coronary Bifurcations: Application of the Crushing Technique Using Sirolimus-Eluting Stents) Study. Circulation. 2009 Jan 6;119(1):71-8. doi: 10.1161/CIRCULATIONAHA.108.808402. Epub 2008 Dec 22.

  PMID: 19103990 RESULT

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

• Antonio Colombo, MD, PhD

  Fondazione Centro San Raffaele del Monte Tabor

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: January 1, 2004
• Primary Completion: May 1, 2005
• Study Completion: April 1, 2009
• Last Updated: February 4, 2010

Record last verified: 2010-02

Locations

IT (1)