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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749424
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : February 4, 2010
Information provided by:
Cordis Corporation

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: SES Phase 4

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  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2004
Actual Primary Completion Date : May 2005
Actual Study Completion Date : April 2009

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

Primary Outcome Measures :
  1. Major Adverse and Cardiac Events (MACE) [ Time Frame: 6 and 12 months post-procedure ]

Secondary Outcome Measures :
  1. Minimal lumen diameter (MLD) [ Time Frame: 6 months ]
  2. Percent diameter stenosis (%DS) [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00749424

Fondazione Centro San Raffaele del Monte Tabor
Milano, Italy, 20132
Sponsors and Collaborators
Cordis Corporation
Principal Investigator: Antonio Colombo, MD, PhD Fondazione Centro San Raffaele del Monte Tabor

Publications of Results:
Responsible Party: Hans-Peter Stoll, MD, Cordis Identifier: NCT00749424     History of Changes
Other Study ID Numbers: CRDIT 00-01/03
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010

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