- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00231257
Sirolimus-Eluting Stent vs. Intravascular Brachytherapy in In-Stent Restenotic Coronary Artery Lesions(SISR)
A Multicenter, Randomized Study of the Sirolimus-Eluting Bx VELOCITY® BALLOON Expandable Stent vs. Intravascular Brachytherapy in the Treatment of Patients With In-Stent Restenotic Coronary Artery Lesions
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Rochester
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
1. The patient has an in-stent restenosis of > 50% (by subjective angiographic determination of the minimal luminal diameter compared to the distal reference diameter) within a native coronary artery which has previously undergone stent placement ( 4 weeks). Lesions must meet ISR Classification I-III.
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:
- The study target lesion has definite or possible thrombus present by angiographic criteria.
- 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.
- Impaired renal function (Serum creatinine > 2.0mg/dl);
- The patient has unstable angina classified as Braunwald III B or C, or is having peri infarction angina.
- The left ventricular ejection fraction is < 40%.
- The target vessel has previously sustained a perforation.
- Totally occluded vessel (TIMI 0 level);
- Prior stent within 5mm of target lesion;
- There is a total occlusion of the restenosed-stent (ISR Classification IV) prior to the interventional procedure.
- Has an ostial target lesion;
- Significant (> 50%) in-stent restenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
Cypher Bx Velocity
|
Sirolimus-Eluting Bx Velocity® Balloon Expandable Stent
|
Aktiv komparator: 2
Brachytherapy
|
Brachytherapy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 9 months post-procedure.
Tidsram: 9 months post-procedure.
|
9 months post-procedure.
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Mål revaskularisering av lesion (TLR) 6 och 9 månader efter proceduren.
Tidsram: 6 och 9 månader efter ingreppet
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6 och 9 månader efter ingreppet
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Mål kärlrevaskularisering (TVR) 6 och 9 månader efter proceduren.
Tidsram: 6 och 9 månader efter ingreppet
|
6 och 9 månader efter ingreppet
|
Angiographic in-lesion and in-stent binary restenosis (³ 50% diameter stenosis) at 6 months post-procedure (by QCA).
Tidsram: 6 months post-procedure
|
6 months post-procedure
|
Post-procedure and six-month in-stent and in-lesion percent diameter stenosis (%DS) and late loss at 6 months post-procedure (by QCA) - [analysis at 6 months chosen so that results from the GAMMA Trial can be used].
Tidsram: 6 months post-procedure
|
6 months post-procedure
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Post-procedure and six-month in-stent and in-lesion minimum lumen diameter (MLD) (by QCA).
Tidsram: Post-procedure and at six-month
|
Post-procedure and at six-month
|
Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-proce
Tidsram: 30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-procedure
|
30 days and 6, 9, and 12-months, and 2, 3, 4, and 5 years post-procedure
|
Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and six months in a subset of patients conducted at 5-7 investigational centers.
Tidsram: post-procedure and six months
|
post-procedure and six months
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Cost associated with the index hospitalization, length of stay, and repeat hospitalizations during the 12 mo post-procedure follow-up.
Tidsram: 12 mo post-procedure
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12 mo post-procedure
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Rate of late thrombosis
Tidsram: Throughout study
|
Throughout study
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: David R. Holmes, Jr., MD, Mayo Clinic - Rochester, Minnesota
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P02-6313
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