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CompletedNCT00749424CACTUSUpdated Feb 4, 2010

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

A Phase 4 interventional study of SES and SES in Coronary Artery Disease, sponsored by Cordis Corporation. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-02-04.

Sponsored by Cordis Corporation · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
350
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Coronary Artery Disease
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 350 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Cordis Corporation is the lead sponsor of 70 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
350 participants (actual)

Study arms

  • Experimental
    1

    crushing technique

    Device: SES

  • Active comparator
    2

    provisional T stenting technique

    Device: SES

Interventions

  • DeviceSES

    CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent

  • DeviceSES

    CYPHER SELECT™ Sirolimus-eluting Balloon-expandable Coronary Stent

06

What researchers measure

Primary outcomes

  1. Major Adverse and Cardiac Events (MACE)

    Time frame: 6 and 12 months post-procedure

Secondary outcomes

  1. Minimal lumen diameter (MLD)

    Time frame: 6 months

  2. Percent diameter stenosis (%DS)

    Time frame: 6 months

07

Study locations

1 site
  • Fondazione Centro San Raffaele del Monte Tabor
    Milano, 20132, Italy
08

References and documents

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. PubMed 19103990 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00749424
Lead sponsor
Cordis Corporation
First posted
Sep 9, 2008
Start date
Jan 2004
Primary completion
May 2005
Completion
Apr 2009
Last update
Feb 4, 2010

Study contacts

Antonio Colombo, MD, PhD
principal investigator · Fondazione Centro San Raffaele del Monte Tabor

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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