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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00749424
First received: September 8, 2008
Last updated: February 3, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: SES
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CORONARY BIFURCATIONS: APPLICATION OF THE CRUSHING TECHNIQUE USING SIROLIMUS-ELUTING STENTS - The "CACTUS" Trial

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • Major Adverse and Cardiac Events (MACE) [ Time Frame: 6 and 12 months post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Minimal lumen diameter (MLD) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Percent diameter stenosis (%DS) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 350
Study Start Date: January 2004
Study Completion Date: April 2009
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749424

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

Publications:
Responsible Party: Hans-Peter Stoll, MD, Cordis
ClinicalTrials.gov Identifier: NCT00749424     History of Changes
Other Study ID Numbers: CRDIT 00-01/03
Study First Received: September 8, 2008
Last Updated: February 3, 2010
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014