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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 opdateret af: 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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Belgien
      • Genk, Belgien, 3600
        • Rekruttering
        • UZ Genk
        • Kontakt:
          • Jo Dens
      • Ghent, Belgien, 9000
        • Rekruttering
        • UZ Ghent
        • Kontakt:
          • Peter Kayaert
      • La Louvière, Belgien, 7100
        • Rekruttering
        • CHU Jolimont
        • Kontakt:
          • Claudiu Ungureanu
      • Liège, Belgien, 4000
        • Rekruttering
        • Chu Liege
        • Kontakt:
          • Lancelotti
      • Mons, Belgien, 7000

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

Ja

Køn, der er berettiget til at studere

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:

    1. Patient <18 years old
    2. Pregnant female
    3. Contraindication to dual antiplatelet therapy
    4. Thrombocytopenia <100 000
    5. Major surgical intervention planned

Exclusion criteria lesion-related:

  1. Significant left main lesion
  2. Bifurcating lesion with a significant side branch to be treated
  3. Lesion length > 25 mm
  4. Chronic total occlusion
  5. Lesion with heavy calcifications where a rotational atherectomy or lithotripsy should be planned
  6. Lesion in a graft
  7. In-stent restenosis lesion
  8. Lesion responsible of a STEMI

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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
Enhed: Conventional Balloon
Conventional balloon
Eksperimentel: 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
Enhed: Wedge Scoring Balloon
Scoring balloon

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
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.
Intravascular ultrasound (IVUS) or quantitative analysis is directly done after procedure

Sekundære resultatmål

Resultatmål
Tidsramme
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
Directly after procedure
Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon
Tidsramme: Directly after procedure
Directly after procedure
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
1 month follow up

Samarbejdspartnere og efterforskere

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

Sponsor

Stephane Carlier

Samarbejdspartnere

BrosMed Medical Co., Ltd
University of Mons

Efterforskere

  • Studieleder: Stéphane Carlier, University of Mons

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 (Faktiske)

1. januar 2020

Primær færdiggørelse (Forventet)

30. juli 2022

Studieafslutning (Forventet)

30. oktober 2022

Datoer for studieregistrering

Først indsendt

13. august 2021

Først indsendt, der opfyldte QC-kriterier

18. august 2021

Først opslået (Faktiske)

24. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. august 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2021

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 007

Plan for individuelle deltagerdata (IPD)

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