- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01223443
Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents (VELETI II)
Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents as a New Approach to MainTaining VeIn Graft Patency and Reducing Cardiac Events
Hypothesis: Sealing moderate SVG lesions with paclitaxel-eluting stents reduces cardiac events (death, myocardial infarction, target vessel revascularization) over the duration of follow-up.
Primary objective: To evaluate the efficacy of stenting moderate SVG lesions with paclitaxel-eluting stents on reducing the first occurrence of the composite of cardiac death, myocardial infarction or repeat revascularization related to the target SVG over the duration of follow-up (minimun of 2-year follow-up.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Quebec, Canada, G1V 4G5
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Clinical indication for cardiac catheterization and SVG angiography
Presence of at least one SVG lesion of 30% to 60% diameter stenoses, by visual estimation, which is not the culprit lesion* responsible for the clinical syndrome of the patient
*If the target lesion is located in the same SVG than the culprit lesion (if present) it has to be at least 4 cm far from the stented segment)
- Written informed consent
Exclusion Criteria:
- Patient < 18 years old
- Ejection fraction < 30%
- Renal insufficiency with creatinine > 200 μmol/l
- Presence of more than 2 moderate SVG stenoses in a single SVG or significant diffuse SVG disease defined as disease covering more than half of the length of the SVG
- Presence of more than 2 SVGs with moderate SVG stenoses
- Unsuccessful angioplasty (residual stenosis >30% and/or TIMI flow <3) of any other lesion treated during the same procedure (culprit lesions will be treated before patient randomization)
- Any significant complication occurring during the angioplasty of the culprit lesion(s) during the same procedure
- SVG lesion located at the distal anastomosis
- SVG lesions located at the proximal anastomosis (lesion length < 5 mm from the SVG ostium)
- Lesion length >25 mm
- SVGs ≤ 3 years ago
- Cardiogenic shock
- Remaining coronary or SVG lesion(s) with treatment (PCI or CABG) planned within the following year
- Pregnancy
- Contraindication to aspirin and/or thienopyridine/ticagrelor treatment
- Allergy to paclitaxel
- Any disease with a limiting life-expectancy (less than 2 years)
- Need for chronic anticoagulation treatment
- Definite presence or high suspicion of thrombus or ulceration in the target lesion
- Target lesion located in the same SVG as the culprit lesion (if present) and distance between the target lesion and the most proximal or distal part of the stent implanted at the culprit lesion < 4 cm
- Vein graft diameter < 2.5 mm
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: PCI-stenting
Stentning af den moderate SVG-læsion med paclitaxel-stenten
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Patienterne randomiseres til enten at stente den moderate SVG-læsion med paclitaxel-stenten eller standard medicinsk behandling
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Ingen indgriben: Standard medical treatment
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
The first occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization related to the target SVG over the duration of follow-up.
Tidsramme: 60 months
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60 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
1-First occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization over the duration of follow-up.
Tidsramme: 60 months
|
60 months
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2-Cardiac death and myocardial infarction; repeat revascularization; and hospitalization due to an acute coronary syndrome.
Tidsramme: 60 months
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60 months
|
3-Total medical costs (at index hospitalization and at follow-up).
Tidsramme: 60 months
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60 months
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4-Costs per major adverse cardiac event (cardiac death, myocardial infarction, revascularization) prevented.
Tidsramme: 60 months
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60 months
|
5-Severe (>60%) SVG lesions or SVG occlusion at the target SVG at 2-year follow-up as determined by 3D computed-tomography.
Tidsramme: 60 months
|
60 months
|
6-Major bleeding complications defined according to the REPLACE-II criteria over the duration of follow-up.
Tidsramme: 60 months
|
60 months
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7-Stent thrombosis defined and classified according to the Academic Research Consortium criteria.
Tidsramme: 60 months
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60 months
|
Samarbejdspartnere og efterforskere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VELETI II
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