Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Feasibility Trial Evaluating Efficacy and Safety of Solitaire™ Thrombus Retrieval Device in the Management of Refractory Thrombus in Patients With Acute Coronary Syndrome (Solitaire)

29. desember 2020 oppdatert av: Paul Ong
The study is designed as a multicentre open label prospective feasibility trial to capture preliminary efficacy and safety information on Solitaire device to plan an appropriate pivotal study.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

We hypothesize that Solitaire device could be effectively and safely used as an adjunctive interventional technique in ACS patients found to have refractory thrombus during PCI.

  1. Primary Objectives To evaluate intra-procedure efficacy of using Solitaire in ACS patients with refractory thrombus.
  2. Secondary Objectives To evaluate clinical efficacy of using Solitaire in ACS patients with refractory thrombus, up to one year post-procedure.

To evaluate safety of using Solitaire in ACS patients with refractory thrombus.

The target enrolment is 51 patients diagnosed with STEMI, NSTEMI or UA and found to have refractory thrombus during PCI. Eligible patients will be identified at the ED or Inpatient ward of the 5 participating hospitals. The projected enrolment period is for two years and follow up for one year. A screening log will be maintained at each site to keep record of patients who were eligible for the study but not enrolled, to establish any selection bias.

Studietype

Intervensjonell

Registrering (Forventet)

51

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Singapore
      • Singapore, Singapore, 768828
        • Rekruttering
        • Khoo Teck Puat Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dr Syed Saqib Imran
      • Singapore, Singapore, 119074
        • Rekruttering
        • National University Heart Centre Singapore (NUHCS)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dr Joshua LOH
      • Singapore, Singapore, 308433
        • Rekruttering
        • Tan Tock Seng Hospital (TTSH)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dr Paul Jau Lueng Ong
      • Singapore, Singapore, 529889
        • Rekruttering
        • Changi General Hospital (CGH) Changi General Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dr Yew Seong Goh
    • Singaproe
      • Singapore, Singaproe, Singapore, 169609
        • Rekruttering
        • National Heart Centre Singapore (NHCS)
        • Ta kontakt med:
        • Hovedetterforsker:
          • Dr Aaron Sung Lung Wong

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

22 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Subjects meeting all of the inclusion criteria listed below will be included in this study:

  1. Index event of ST segment elevation or non-ST segment elevation MI or Unstable Angina defined as:

    1. Presentation to hospital with symptoms of myocardial ischemia (Chest pain or angina equivalent) lasting for ≥10 minutes at rest

      AND 1 of the following:

    2. Persistent ST segment elevation ≥1mm (0.1 mV) in two or more contiguous limb leads or ≥2mm (0.2 mV) in ) in one or more contiguous precordial leads OR
    3. New or presumed new left bundle branch block (LBBB) OR
    4. ST segment depression ≥1mm (0.1 mV) in two or more contiguous leads (not known to be pre-existing or due to a known cause such as LV hypertrophy or digoxin) OR
    5. Troponin T or I greater than the laboratory upper normal limit.

  2. Referred for urgent or emergency PCI AND Thrombus burden of TG 4 or above OR TIMI flow grade of 1 or less in at least one native infarct related artery following either

    1. Manual aspiration thrombectomy OR
    2. Balloon Angioplasty OR
    3. AngioJet RT OR
    4. Patient having deferred PCI due to heavy thrombus but continue to demonstrate recalcitrant thrombus upon repeat angiography.

Exclusion Criteria:

Subjects meeting any of the exclusion criteria listed below will be excluded from this study:

  1. Age ≤ 21 years
  2. Cardiogenic shock
  3. killip class 3 or above at presentation

  4. Known relative contraindications for the use of Solitaire:

    1. Prior stent in infarct related artery
    2. Significant proximal stenosis OR Ostial lesion at angiography
    3. Extensive calcification
  5. Life expectancy less than six months due to non-cardiac condition
  6. Participants categorised as vulnerable subjects (ex: prisoners, pregnant women, and mentally disabled persons)
  7. Patients at high risk of being lost to follow up (ex: non-residents)
  8. Participation in any study with an investigational drug or device within the last 30 days
  9. Patients who are unable to provide informed consent prior to any procedure .

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: open label
open label prospective feasibility trial.
Enhet: Solitaire™ thrombus retrieval device
After consent has been obtained, interventional cardiologist selects the proper solitaire device size per device-specific instructions for use. Adjunctive intervention with Solitaire will be done with a maximum of 2 device deployments. Do not perform more than three recovery attempts in the same vessel using the devices (Maximum of 2 attempts per device per subject). Do not reposition each device more than two times. TIMI flow, thrombus grade and myocardial blush grade will be assessed immediately upon completion of procedure. If recanalization is deemed inadequate by the interventional cardiologist, rescue treatment will follow as per current clinical practice. All other procedures followed will be as clinically indicated.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of successful recanalization defined as an immediate post-procedure Thrombolysis in Myocardial Infarction (TIMI) flow of 2 or 3.
Tidsramme: immediate post-procedure
Primary Efficacy Endpoint
immediate post-procedure
Occurrence of any stroke
Tidsramme: immediate post-procedure up to 30 days
Occurrence of any stroke, defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours, from immediate post-procedure up to 30 days.
immediate post-procedure up to 30 days
Incidence of study device-related Serious Adverse Events (SAEs) up to 30 days.
Tidsramme: up to 30 days
Primary Safety Endpoint
up to 30 days
Incidence of emboli in new territory (ENT) at 24 hrs ± 8 hrs post procedure (ENT: Embolization territories outside of the target downstream territory).
Tidsramme: at 24 hours ± 8 hours post procedure
Primary Safety Endpoint
at 24 hours ± 8 hours post procedure

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of successful thrombus resolution defined as an immediate post-procedure thrombus burden of thrombus grade (TG) 1 or less
Tidsramme: immediate post-procedure
Secondary Endpoints
immediate post-procedure
Rate of successful recanalization defined as a reduction in corrected TIMI frame count after use of the Solitaire device.
Tidsramme: immediate post-procedure
Secondary Endpoints
immediate post-procedure
Rate of successful myocardial perfusion defined as an immediate post-procedure myocardial blush grade (MBG) of 2 or more
Tidsramme: immediate post-procedure
Secondary Endpoints
immediate post-procedure
Rate of device success defined as successful delivery and retrieval of the device without complication
Tidsramme: immediate post- procedure
Secondary Endpoints
immediate post- procedure
Occurrence of major adverse cardiac and cerebrovascular events (MACCE)
Tidsramme: up to one year post-procedure
Occurrence of major adverse cardiac and cerebrovascular events (MACCE), defined as composite of all cause death, myocardial infarction, target vessel revascularisation or stroke, up to one year post-procedure.
up to one year post-procedure
All-cause mortality through 90 days post procedure.
Tidsramme: 90 days post procedure
Secondary Endpoints
90 days post procedure

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Paul Ong

Etterforskere

  • Hovedetterforsker: Paul Jau Lueng Ong, Paul Ong Jau Lueng

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

16. juli 2019

Primær fullføring (Forventet)

30. juni 2022

Studiet fullført (Forventet)

30. september 2022

Datoer for studieregistrering

Først innsendt

28. oktober 2020

Først innsendt som oppfylte QC-kriteriene

29. desember 2020

Først lagt ut (Faktiske)

31. desember 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. desember 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. desember 2020

Sist bekreftet

1. desember 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • DSRB 2018/00865

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere