Back to resultsWEDGES: Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization (WEDGES)
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Wedge Scoring Balloon
Conventional Balloon
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- UZ GenkRecruiting
- UZ GhentRecruiting
- CHU JolimontRecruiting
- CHU LiègeRecruiting
- CHU Ambroise ParéRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional balloon predilation
Scoring balloon predilation
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Rate of successful predilatation of calcified lesions of a scoring semi-compliant/non-compliant balloon and semi-compliant (SC)/ non-compliant (NC) balloon
Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon
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.
Full Information
NCT ID
NCT05019443
First Posted
August 13, 2021
Last Updated
August 18, 2021
Sponsor
Stephane Carlier
Collaborators
BrosMed Medical Co., Ltd, University of Mons
1. Study Identification
Unique Protocol Identification Number
NCT05019443
Brief Title
WEDGES: Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization
Acronym
WEDGES
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 30, 2022 (Anticipated)
Study Completion Date
October 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Stephane Carlier
Collaborators
BrosMed Medical Co., Ltd, University of Mons
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional balloon predilation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Scoring balloon predilation
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Wedge Scoring Balloon
Intervention Description
Scoring balloon
Intervention Type
Device
Intervention Name(s)
Conventional Balloon
Intervention Description
Conventional balloon
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Intravascular ultrasound (IVUS) or quantitative analysis is directly done after procedure
Secondary Outcome Measure Information:
Title
Rate of successful predilatation of calcified lesions of a scoring semi-compliant/non-compliant balloon and semi-compliant (SC)/ non-compliant (NC) balloon
Time Frame
Directly after procedure
Title
Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon
Time Frame
Directly after procedure
Title
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.
Time Frame
1 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane Carlier
Phone
0032475812765
Email
stephane.carlier@umons.ac.be
First Name & Middle Initial & Last Name or Official Title & Degree
Chadi Ghafari
Email
chadi.ghafari@umons.ac.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Carlier
Organizational Affiliation
University of Mons
Official's Role
Study Director
Facility Information:
Facility Name
UZ Genk
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jo Dens
Facility Name
UZ Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Kayaert
Facility Name
CHU Jolimont
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudiu Ungureanu
Facility Name
CHU Liège
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lancelotti
Facility Name
CHU Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Carlier
Email
stephane.carlier@umons.ac.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
WEDGES: Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization
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