WEDGES: Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization (WEDGES)
18. august 2021 oppdatert av: Stephane Carlier
WEDGES: a Prospective, Multi-center Randomized Trial for the Evaluation of Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization
Stent under-expansion during percutaneous coronary intervention (PCI) is one of the suboptimal results associated with a higher risk of restenosis and thrombosis. In order to obtain an optimal stent expansion, especially in lesions with calcific or fibrotic plaque, the appropriate lesion preparation before stent implantation is a crucial phase.
For this, different devices are used in everyday practices, including non-compliant balloon (NC), scoring / cutting balloons or rotational atherectomy; however, their effectiveness depends on the experience and skill of the operator. The purpose of this study is to assess the feasibility, efficacy and safety of a novel scoring balloon intended to treat calcific or fibrotic plaque of a coronary lesion
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Stéphane Carlier
- Telefonnummer: 0032475812765
- E-post: stephane.carlier@umons.ac.be
Studer Kontakt Backup
- Navn: Chadi Ghafari
- E-post: chadi.ghafari@umons.ac.be
Studiesteder
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Genk, Belgia, 3600
- Rekruttering
- UZ Genk
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Ta kontakt med:
- Jo Dens
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Ghent, Belgia, 9000
- Rekruttering
- UZ Ghent
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Ta kontakt med:
- Peter Kayaert
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La Louvière, Belgia, 7100
- Rekruttering
- CHU Jolimont
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Ta kontakt med:
- Claudiu Ungureanu
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Liège, Belgia, 4000
- Rekruttering
- Chu Liege
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Ta kontakt med:
- Lancelotti
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Mons, Belgia, 7000
- Rekruttering
- CHU Ambroise Paré
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Ta kontakt med:
- Stéphane Carlier
- E-post: stephane.carlier@umons.ac.be
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patient written consent is given A de novo lesion
- Mild to moderate burden of calcifications detected on two orthogonal views using normal radiation power
Exclusion Criteria:
Exclusion criteria patient-related:
- Patient <18 years old
- Pregnant female
- Contraindication to dual antiplatelet therapy
- Thrombocytopenia <100 000
- Major surgical intervention planned
Exclusion criteria lesion-related:
- Significant left main lesion
- Bifurcating lesion with a significant side branch to be treated
- Lesion length > 25 mm
- Chronic total occlusion
- Lesion with heavy calcifications where a rotational atherectomy or lithotripsy should be planned
- Lesion in a graft
- In-stent restenosis lesion
- Lesion responsible of a STEMI
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Conventional balloon predilation
the target lesion can be prepared according to standard clinical practice using SC balloons sized 0.8-1:1.
Stenting using a drug-eluting stent (DES) is performed and the inflation pressure for delivery is noted, as well as the expected balloon diameter at that pressure.
2 enhanced stent imaging acquisitions (StentBoost or equivalent depending on the X-ray system used), are acquired in 2 orthogonal views.
Post dilatation can be performed at operator discretion followed by a final acquisition of 2 similar orthogonal views with enhanced stent imaging.
Intravascular imaging is left to the operator's discretion and is encouraged
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Conventional balloon
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Eksperimentell: Scoring balloon predilation
the target lesion must be prepared with a scoring balloon (SC) inflated 3 times at nominal pressure.
To allow the scoring balloon to cross the lesion, it might be necessary to predilate with a small compliant balloon.
The size of the scoring balloon to be used for is based on the size of the vessel.
Stenting using a DES is performed and the inflation pressure for delivery is noted, as well as the expected balloon diameter at that pressure.
2 enhanced stent imaging acquisitions (StentBoost or equivalent depending on the X-ray system used), are acquired in 2 orthogonal views.
Post dilatation can be performed at operator discretion followed by a final acquisition of 2 similar orthogonal views with enhanced stent imaging.
Intravascular imaging is left to the operator's discretion and is encouraged
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Scoring balloon
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Stent expansion in calcified lesions assessed by stent diameter calculation using quantitative and intravascular analysis after lesion preparation using a scoring balloon is superior to conventional lesion preparation
Tidsramme: Intravascular ultrasound (IVUS) or quantitative analysis is directly done after procedure
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The measure of stent expansion in calcified coronary lesions as assessed by quantitative coronary angiography, enhanced stent imaging and intravascular ultrasound after lesion preparation using the novel scoring semi-compliant and noncompliant balloons are superior (p<0.05) to semi compliant and non-compliant balloons.
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Intravascular ultrasound (IVUS) or quantitative analysis is directly done after procedure
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Rate of successful predilatation of calcified lesions of a scoring semi-compliant/non-compliant balloon and semi-compliant (SC)/ non-compliant (NC) balloon
Tidsramme: Directly after procedure
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Directly after procedure
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Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon
Tidsramme: Directly after procedure
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Directly after procedure
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Rate of procedural complication (composite of cardiac death, myocardial infarction, coronary artery perforation and cardiac tamponade) of a scoring balloon and a SC/NC balloon followed by stenting.
Tidsramme: 1 month follow up
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1 month follow up
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Stéphane Carlier, University of Mons
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)
1. januar 2020
Primær fullføring (Forventet)
30. juli 2022
Studiet fullført (Forventet)
30. oktober 2022
Datoer for studieregistrering
Først innsendt
13. august 2021
Først innsendt som oppfylte QC-kriteriene
18. august 2021
Først lagt ut (Faktiske)
24. august 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. august 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. august 2021
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 007
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