- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03522038
Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)
Functional Assessment-guided Angioplasty in Patients With Coronary Chronic Total Occlusion (FAGA-CTO)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
PCI for CTO has dramatically changed in recent years. Although, with the improvement of devices and refinement of operator techniques, PCI of CTO can currently be performed with high success and low complication rates at experienced centers, the clinical benefit of recanalization of CTO is still a matter of debate. Accumulating evidence suggests that the improvement of left ventricular functional and prognosis is closely related with the area of viable myocardium, which has the potential for contractile recovery after revascularization. For the majority of interventional cardiologists, coronary angiography is the only invasive test deemed necessary for clinical decision-making, despite its weak ability to predict the functional impact of vascular occlusion on the subtended myocardium. To overcome this limitation, adjunctive diagnostic tools for functional evaluation, such as FFR, CFR, IMR and D-SPECT, have been introduced. In non-CTO patients, physiology-guided revascularization strategy has been definitely proven to be better than angiography-guided strategy in pivotal landmark studies. However, the clinical value of these functional parameters for the PCI of CTO is still unknown.
The aim of this study was to determine whether functional evaluation is a better predictor of clinical outcome in patients with CTO undergoing PCI.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 and ≤80
- Patients diagnosed with CTO by coronary angiography
- Patient planned to receive PCI
- Diameter of CTO vessel > 2.25 mm
Exclusion Criteria:
- Age >80 or <18
- Myocardial infarction with 1 months
- Inability to give informed consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change from Baseline FFR at 6 months after CTO PCI
Tidsramme: At baseline and 6 months after CTO PCI
|
FFR measurement in donor vessels at were performed simultaneously using pressure wires (Abbot) before attempting the CTO vessel.
FFR measurement in the CTO vessels were performed after the wire arrived at the distal true lumen through antegrade or retrograde route.
The FFR in donor and CTO vessels were measured again after successful stenting of CTO vessels.
|
At baseline and 6 months after CTO PCI
|
Change from Baseline FFR at 6 months after CTO PCI
Tidsramme: At baseline and 6 months after CTO PCI
|
CFR measurement in donor vessels at were performed simultaneously using pressure wires (Abbot) before attempting the CTO vessel.
CFR measurement in the CTO vessels were performed after the wire arrived at the distal true lumen through antegrade or retrograde route.
The CFR in donor and CTO vessels were measured again after successful stenting of CTO vessels.
|
At baseline and 6 months after CTO PCI
|
Change from Baseline Myocardial perfusion at 6 months after CTO PCI
Tidsramme: At baseline and 6 months after CTO PCI
|
The myocardial perfusion before and after CTO PCI was evaluated by dynamic SPECT.
|
At baseline and 6 months after CTO PCI
|
Change from Baseline Myocardial Viability at 6 months after CTO PCI
Tidsramme: At baseline and 6 months after CTO PCI
|
The myocardial viability before and after CTO PCI was evaluated by PET-MRI.
|
At baseline and 6 months after CTO PCI
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
MACE
Tidsramme: 6 months after CTO PCI
|
A major adverse cardiac event (MACE) was defined as the occurrence of cardiac death, nonfatal MI, and target lesion revascularization during the follow-up period.
|
6 months after CTO PCI
|
In-stent restenosis
Tidsramme: 6 months after CTO PCI
|
In-stent restenosis was defined as >50% diameter stenosis by quantitative coronary angiography within a previously stented CTO vessel segment.
|
6 months after CTO PCI
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ZS-CV-201801
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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