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

CORONARY BIFURCATIONS: APPLICATION OF THE CRUSHING TECHNIQUE USING SIROLIMUS-ELUTING STENTS - The "CACTUS" Trial

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: SES

Detailed Description

This is a prospective, randomized study that will be conducted at up to 5 centers in Italy. All patients who meet the eligibility criteria will be treated with the Cypher SelectTM Stent and Stent Delivery System (SDS). Patients will have repeat angiography at six months, with clinical follow-up to 2 years.

• Study Type: Interventional
• Enrollment (Actual): 350
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy, 20132
    • Fondazione Centro San Raffaele del Monte Tabor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Is a male or non-pregnant female patient >= 18 years of age [NOTE: Females of child-bearing potential must have a negative pregnancy test];
2. 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;
3. Has at least TIMI I coronary flow in both the main and side branches;
4. 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;
5. Has a true bifurcation lesion defined as stenosis > 50% in both the main branch and the ostium of the side branch;
6. Has a maximum treatable main or side branch lesion length <=28 mm;
7. Has a main branch vessel that is >= 2.5 mm and <= 3.5 mm in diameter by on-line QCA proximal to the bifurcation;
8. Has a side branch vessel that is >= 2.25 mm and <= 3.5 mm in diameter by on-line QCA;
9. Is an acceptable candidate for coronary artery bypass surgery (CABG);
10. Is willing to comply with the specified follow-up evaluation;
11. The patient or legally authorized representative must provide written informed consent prior to the procedure.

Exclusion Criteria:

1. 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;
2. Has unstable angina classified as Braunwald A I-III, B&C III;
3. Has a bifurcation lesion in a non protected left main;
4. Has an ejection fraction <= 35%;
5. Has known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or sirolimus;
6. Has a known serious allergy to contrast media or stainless steel that cannot be managed medically;
7. Has impaired renal function (creatinine > 3.0 mg/dl);
8. There is presence of thrombus in the bifurcation lesion;
9. Has a target lesion with excessive tortuousity unsuitable for stent delivery and deployment;
10. Has a totally occluded vessel;
11. Is the recipient of a heart transplant;
12. Has a significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
13. Is currently participating in an investigational drug or another device study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; crushing technique	Device: SES; CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent
Active Comparator: 2; provisional T stenting technique	Device: SES; CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major Adverse and Cardiac Events (MACE)	6 and 12 months post-procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Minimal lumen diameter (MLD)	6 months
Percent diameter stenosis (%DS)	6 months

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Investigators: Principal Investigator: Antonio Colombo, MD, PhD, Fondazione Centro San Raffaele del Monte Tabor

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2004
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: September 8, 2008
• First Submitted That Met QC Criteria: September 8, 2008
• First Posted (Estimate): September 9, 2008

Study Record Updates

• Last Update Posted (Estimate): February 4, 2010
• Last Update Submitted That Met QC Criteria: February 3, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CRDIT 00-01/03