WEDGES: Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05019443
• Other study ID #: 007
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: August 2021
• Source: University of Mons
• Contact: Stéphane Carlier
• Phone: 0032475812765
• Email: stephane.carlier[@]umons.ac.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Wedge Scoring Balloon
Scoring balloon
• Conventional Balloon
Conventional balloon

Locations

Country	Name	City	State
Belgium	UZ Genk	Genk
Belgium	UZ Ghent	Ghent
Belgium	CHU Jolimont	La Louvière
Belgium	CHU Liège	Liège
Belgium	CHU Ambroise Paré	Mons

Sponsors (3)

Lead Sponsor	Collaborator
Stephane Carlier	BrosMed Medical Co., Ltd, University of Mons

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon		Directly after procedure
Secondary	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