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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Conventional Balloon; Device: Wedge Scoring Balloon

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphane Carlier; Phone Number: 0032475812765; Email: stephane.carlier@umons.ac.be
• Study Contact Backup: Name: Chadi Ghafari; Email: chadi.ghafari@umons.ac.be

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Recruiting
    • UZ Genk
    • Contact: Jo Dens
  • Ghent, Belgium, 9000
    • Recruiting
    • UZ Ghent
    • Contact: Peter Kayaert
  • La Louvière, Belgium, 7100
    • Recruiting
    • CHU Jolimont
    • Contact: Claudiu Ungureanu
  • Liège, Belgium, 4000
    • Recruiting
    • Chu Liege
    • Contact: Lancelotti
  • Mons, Belgium, 7000
    • Recruiting
    • CHU Ambroise Paré
    • Contact: Stéphane Carlier; Email: stephane.carlier@umons.ac.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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:

  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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: Conventional Balloon; Conventional balloon
Experimental: 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	Device: Wedge Scoring Balloon; Scoring balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of successful predilatation of calcified lesions of a scoring semi-compliant/non-compliant balloon and semi-compliant (SC)/ non-compliant (NC) balloon	Directly after procedure
Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon	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.	1 month follow up

Collaborators and Investigators

• Sponsor: Stephane Carlier
• Collaborators: BrosMed Medical Co., Ltd; University of Mons
• Investigators: Study Director: Stéphane Carlier, University of Mons

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No