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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00749424
First Posted: September 9, 2008
Last Update Posted: February 4, 2010
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.
Information provided by:
Cordis Corporation
September 8, 2008
September 9, 2008
February 4, 2010
January 2004
May 2005   (Final data collection date for primary outcome measure)
Major Adverse and Cardiac Events (MACE) [ Time Frame: 6 and 12 months post-procedure ]
Same as current
Complete list of historical versions of study NCT00749424 on ClinicalTrials.gov Archive Site
  • Minimal lumen diameter (MLD) [ Time Frame: 6 months ]
  • Percent diameter stenosis (%DS) [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
The Study of the Crushing Technique Application Using SES in Coronary Bifurcations.
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
Device: SES
CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent
  • Experimental: 1
    crushing technique
    Intervention: Device: SES
  • Active Comparator: 2
    provisional T stenting technique
    Intervention: Device: SES
Colombo A, Bramucci E, Saccà 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
April 2009
May 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00749424
CRDIT 00-01/03
Yes
Not Provided
Not Provided
Hans-Peter Stoll, MD, Cordis
Cordis Corporation
Not Provided
Principal Investigator: Antonio Colombo, MD, PhD Fondazione Centro San Raffaele del Monte Tabor
Cordis Corporation
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP