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- Essai clinique NCT05019443
WEDGES: Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization (WEDGES)
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Stéphane Carlier
- Numéro de téléphone: 0032475812765
- E-mail: stephane.carlier@umons.ac.be
Sauvegarde des contacts de l'étude
- Nom: Chadi Ghafari
- E-mail: chadi.ghafari@umons.ac.be
Lieux d'étude
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Genk, Belgique, 3600
- Recrutement
- UZ Genk
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Contact:
- Jo Dens
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Ghent, Belgique, 9000
- Recrutement
- UZ Ghent
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Contact:
- Peter Kayaert
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La Louvière, Belgique, 7100
- Recrutement
- CHU Jolimont
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Contact:
- Claudiu Ungureanu
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Liège, Belgique, 4000
- Recrutement
- CHU Liege
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Contact:
- Lancelotti
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Mons, Belgique, 7000
- Recrutement
- CHU Ambroise Pare
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Contact:
- Stéphane Carlier
- E-mail: stephane.carlier@umons.ac.be
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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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
Délai: 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
Délai: 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.
Délai: 1 month follow up
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1 month follow up
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Stéphane Carlier, University of Mons
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 007
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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