FROST 4: Study of the Optimal Spreading of a Coronary Stent Guided With Pressure Into the Coronary Arteries
Prospective Study Randomized Multicentric On the Optimization Of the Installation Of Stent By Measurement Of the Intra-Coronary Pressure
Hypothesis : it is known that the stent must be well opened out in order to avoid restenosis into the stent. Intra coronary pressure would allow the stent to be well deployed and so the restenose into the stent should diminish.
Primary purpose : this study intend to test the hypothesis of optimal spreading of coronary stent guided with pressure into coronary arteritis comparing 2 strategies with patients having a coronary procedure with stent, excluded patients with myocardial infarction.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
It is a randomized study, intending to treat, comparing the optimisation of the opening out of a stent into a coronar artery either guided with angiographic images only or with the assistance of pressure measurements plus angiographic control.
Several French centers participate to demonstrate superiority of one strategy. The criterion of principal judgement is the whole of cardiac events, criterion made up with the cardiac death, myocardial infarction, revascularisation by coronary bridging and/or angioplasty and positivity of the effort test.
Secondary criterions are :
- comparing cost to efficacy of the two strategies
- evaluating the angiographic restenosis into an under group of 200 patients (100 patients into each group)
- determining the optimal threshold of measurement of intra coronary pressure in a multicentric population
- comparing the ability of the different stents used to optimised the intra coronary pressure measurements
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Paris, Frankrike, 75015
- European Georges Pompidou's Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- patient sent to coronal angioplasty with putting of an active stent to treat a restenosis
Exclusion Criteria:
- acute myocardial infarction
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 1
Intra coronary measures of pressure
|
Intra coronary measures of pressure
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The first group of patients will have a coronary procedure with stent and his good deployment will be controlled with angiographic images
Tidsramme: during de study
|
The first group of patients will have a coronary procedure with stent and his
|
during de study
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
At 6 months cardiac events will be registered: patients will undergo a scintigraphic and effort test with thallium and a clinical exam
Tidsramme: during the study
|
At 6 months cardiac events will be registered: patients will undergo a
|
during the study
|
|
At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered
Tidsramme: during the study
|
At 12 and 18 months they will undergo a clinical exam and cardiac events will be registered
|
during the study
|
|
Complementary examination
Tidsramme: during the study
|
Complementary examination
|
during the study
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Antoine LAFONT, Pr,MD,PhD, Assistance Publique - Hôpitaux de Paris
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- P001003
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