Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)
NCT ID: NCT00231257
Last Updated: 2009-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
384 participants
INTERVENTIONAL
2003-02-28
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Cypher Bx Velocity
Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
2
Brachytherapy
Brachytherapy
Brachytherapy
Interventions
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Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
Brachytherapy
Brachytherapy
Eligibility Criteria
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Inclusion Criteria
2\. The patient has a history, signs of, or laboratory studies that suggest coronary ischemia attributable to the target stenosis. The diagnosis of angina pectoris is defined by Canadian Cardiovascular Society Classification (CCS I, II, III, or IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II) OR patients with documented silent ischemia;
3\. The study target lesion must be located in an in-stent restenotic native coronary artery measuring \> 2.75mm and 3.5mm in diameter and \> 15mm and 40mm in length to allow treatment with a maximum of three 18mm stents. The target lesion must have undergone coronary interventional treatment \> 4 weeks previously. Patients with one or more prior percutaneous coronary interventions at the target lesion are acceptable candidates.
4\. The vessel 1cm distal to the target lesion is \> 2.5mm in diameter;
5\. Ejection Fraction must be \> 40%;
6\. The study target lesion cannot be located in a vessel containing a second lesion requiring treatment at the time of the procedure.
7\. Male or non-pregnant female patients \> 18 years of age inclusive. NOTE: Females of child-bearing potential must have a negative pregnancy test (urine or serum) prior to enrollment and must use birth control for 6 months.
Exclusion Criteria
2. The patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK \> 2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remain above normal at the time of treatment.
3. Impaired renal function (Serum creatinine \> 2.0mg/dl);
4. The patient has unstable angina classified as Braunwald III B or C, or is having peri infarction angina.
5. The left ventricular ejection fraction is \< 40%.
6. The target vessel has previously sustained a perforation.
7. Totally occluded vessel (TIMI 0 level);
8. Prior stent within 5mm of target lesion;
9. There is a total occlusion of the restenosed-stent (ISR Classification IV) prior to the interventional procedure.
10. Has an ostial target lesion;
11. Significant (\> 50%) in-stent restenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
18 Years
ALL
No
Sponsors
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Cordis Corporation
INDUSTRY
Responsible Party
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Mayo Clinic Rochester, Minnesota
Principal Investigators
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David R. Holmes, Jr., MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic - Rochester, Minnesota
Locations
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Mayo Clinic Rochester
Rochester, Minnesota, United States
Countries
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References
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Holmes DR Jr, Teirstein P, Satler L, Sketch M, O'Malley J, Popma JJ, Kuntz RE, Fitzgerald PJ, Wang H, Caramanica E, Cohen SA; SISR Investigators. Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. JAMA. 2006 Mar 15;295(11):1264-73. doi: 10.1001/jama.295.11.1264. Epub 2006 Mar 12.
Holmes DR Jr, Teirstein PS, Satler L, Sketch MH Jr, Popma JJ, Mauri L, Wang HP, Schleckser PA, Cohen SA; SISR Investigators. 3-year follow-up of the SISR (Sirolimus-Eluting Stents Versus Vascular Brachytherapy for In-Stent Restenosis) trial. JACC Cardiovasc Interv. 2008 Aug;1(4):439-48. doi: 10.1016/j.jcin.2008.05.010.
Other Identifiers
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P02-6313
Identifier Type: -
Identifier Source: org_study_id