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The Bioresorbable Implants for Scaffolding Obstructions in Randomized Bifurcations (BIFSORB) Study (BIFSORB)

5. januar 2021 opdateret af: Evald Hoej Christiansen, Aarhus University Hospital Skejby

Bioresorbable Vascular Stents for Treatment of Coronary Bifurcation Lesions Assessed by Optical Coherence Tomography - The BIFSORB Study

Coronary artery disease is often treated by implantation of permanent metallic stents.Coronary stents are required in the early healing phase after balloon dilatation but constitute a lifelong foreign body. New bioresorbable stents have been developed and are believed to improve long-term safety. The purpose of this study is to compare the safety and vessel healing after treatment of simple bifurcation lesions with the CE-marked bioresorbable stents Absorb and Desolve.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

BIFSORB is a prospective, randomized multicenter trial comparing 6-month healing outcome after treatment of simple coronary bifurcation lesions by Absorb or Desolve BRS. for treatment of coronary bifurcation lesions.

BRS are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time.

The aim of this study is to compare the 6 months safety and vessel healing after treatment of coronary bifurcation lesions by the Desolve or Absorb BRS.

Hypothesis: Treatment of coronary bifurcation lesions using Absorb and Desolve bioresorbable stents is safe. Treatment of coronary bifurcation lesions by Desolve BRS is associated with a lower index of adverse vessel wall features (main vessel area stenosis, acquired malapposition, evaginations, late recoil, single end attached protruding struts, side branch ostial area stenosis) at 6 months compared to treatment with Absorb BRS.

Methods:

Prospective, open label, single blind, randomized, feasibility and safety pilot study with inclusion of 120 patients. Randomization 1:1 to Absorb or Desolve. Planned 6- and 24-month follow-up by OCT and follow-up for clinical endpoints until 10 years.

Eligible patients with a bifurcation lesion are treated by the provisional technique with mandatory jailing of the side branch and provisional opening of side branch ostium by the mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No dilatation beyond the expansion limits of the BRS.

The patients are assessed by optical coherence tomography (OCT) before, during and after implantation of the Absorb or Desolve BRS at baseline procedure and again at 6- and 24-month follow-up, or before if they are readmitted with a possible target lesion failure.

The operator is not blinded to pre-PCI OCT images that may be used for sizing and positioning of the scaffolds. Procedural OCT may be used to optimize scaffold implantation before performing final OCT.

Results are reported as clinical safety at 6 months (myocardial infarction, revascularization, death) and stent healing index by OCT including malapposition, stent coverage, side branch ostial area late loss, fracture and evaginations.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Aarhus N, Danmark, 8200
        • Aarhus University Hospital
      • Odense, Danmark
        • Odense University Hospital
      • Roskilde, Danmark
        • Zealand University Hospital, Roskilde
  • Letland
      • Riga, Letland
        • Latvian Heart Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Stable angina pectoris
  • Age > 18 years
  • Stabilized non-ST elevation myocardial infarction
  • Silent angina
  • De novo coronary bifurcation lesions at LAD/diagonal, CX/obtuse marginal, RCA-PDA/posterolateral branch
  • All Medina classes except Medina x.x.1
  • Diameter of side branch ≥ 2.5 mm
  • Signed informed consent

Exclusion Criteria:

  • ST-elevation infarction within 48 hours
  • Expected survival < 1 year
  • Severe heart failure (NYHA≥III)
  • S-creatinine > 120 µmol/L
  • Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine, everolimus or novolimus
  • Unable to cover main vessel lesion with one scaffold
  • Severe tortuosity
  • Severe calcification

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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: Absorb
Randomization to implantation of Absorb BVS in bifurcation lesion
Enhed: Absorb
Randomization to implantation of Absorb BVS in bifurcation lesion
Eksperimentel: Desolve
Randomization to implantation of Desolve BRS in bifurcation lesion
Enhed: Desolve
Randomization to implantation of Desolve BRS in bifurcation lesion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.
Tidsramme: 6 months
Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.
6 months
Index of adverse vessel wall features
Tidsramme: 6 months
Side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Optisk kohærens tomografi endepunkt: Akut trombe på stivere
Tidsramme: Baseline
Baseline
Angiografisk endepunkt: Ostial sidegren akut forstærkning efter stenting af hovedkar
Tidsramme: Baseline
Baseline
Angiografisk endepunkt: Ostial distalt hovedkar akut forstærkning efter hovedkarstenting
Tidsramme: Baseline
Baseline
Angiografisk endepunkt: Akut forstærkning af proksimal hovedkar efter stenting af hovedkar
Tidsramme: Baseline
Baseline
Optical coherence tomography endpoint: acute malapposition
Tidsramme: Baseline
Baseline
Optical coherence tomography endpoint: acquired malapposition
Tidsramme: 6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: persistent malapposition
Tidsramme: 6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Coverage of jailing struts
Tidsramme: 6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Extra stent lumen (including evaginations)
Tidsramme: Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Late stent recoil
Tidsramme: 6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: stent fracture
Tidsramme: Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts
Tidsramme: Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Ostial strut loss
Tidsramme: Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Mean neointimal thickness
Tidsramme: 6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Stent strut coverage
Tidsramme: 6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Minimal luminal area in segmental analysis
Tidsramme: Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Minimal stent area in segmental analysis
Tidsramme: Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Minimum scaffold expansion area %
Tidsramme: Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Segmental area stenosis
Tidsramme: Baseline, 6 and 24 months
Baseline, 6 and 24 months
Optical coherence tomography endpoint: Healing above calcified plaque
Tidsramme: 6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Healing above lipid plaque
Tidsramme: 6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Late thrombus on struts
Tidsramme: 6 and 24 months
6 and 24 months
Optical coherence tomography endpoint: Acute expansion
Tidsramme: Baseline
Measured in segments with; 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation
Baseline
Optical coherence tomography endpoint:Late recoil
Tidsramme: 6 and 24 months
Measured in segments with; 1) calcified plaque, 2) lipid plaque, 3) area after predilatation < 30% of reference area, 4) stenosed segments (>50% area stenosis) with no dissections after predilatation
6 and 24 months
Angiographic endpoint: Ostial side branch area stenosis
Tidsramme: Baseline, 6 and 24 months
Baseline, 6 and 24 months
Angiographic endpoint: Ostial side branch late loss
Tidsramme: 6 and 24 months
6 and 24 months
Angiographic endpoint: Ostial distal main vessel area stenosis
Tidsramme: Baseline, 6 and 24 months
Baseline, 6 and 24 months
Angiographic endpoint: Ostial distal main vessel late loss
Tidsramme: 6 and 24 months
6 and 24 months
Angiographic endpoint: Proximal main vessel area stenosis
Tidsramme: Baseline, 6 and 24 months
Baseline, 6 and 24 months
Angiographic endpoint: Proximal main vessel late loss
Tidsramme: 6 and 24 months
6 and 24 months
Angiographic endpoint: Minimal luminal area of all segments
Tidsramme: Baseline, 6 and 24 months
Baseline, 6 and 24 months
Procedural endpoints: Procedure time
Tidsramme: Baseline
From sheath insertion to closure device excluding treatment of other vessels
Baseline
Procedural endpoints: Contrast use
Tidsramme: Baseline
Baseline
Procedural endpoints: Fluoroscopy time
Tidsramme: Baseline
Baseline

Andre resultatmål

Resultatmål
Tidsramme
Clinical endpoints: Myocardial infarction
Tidsramme: 10 years
10 years
Clinical endpoints: Target lesion failure
Tidsramme: 10 years
10 years
Clinical endpoints: Target lesion revascularization
Tidsramme: 10 years
10 years
Clinical endpoints: Stent thrombosis
Tidsramme: 10 years
10 years
Clinical endpoints: Cardiac death
Tidsramme: 10 years
10 years
Clinical endpoints: Non-Cardiac death
Tidsramme: 10 years
10 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Aarhus University Hospital Skejby

Efterforskere

  • Ledende efterforsker: Evald H Christiansen, MD, PhD, Aarhus University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2016

Primær færdiggørelse (Forventet)

1. november 2026

Studieafslutning (Forventet)

1. september 2028

Datoer for studieregistrering

Først indsendt

22. november 2016

Først indsendt, der opfyldte QC-kriterier

22. november 2016

Først opslået (Skøn)

25. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1-10-72-215-14

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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Placeringer

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