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

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Device: Conventional Balloon; Device: Wedge Scoring Balloon

• Registration Number: NCT05019443
• Lead Sponsor: Stephane Carlier

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2021-08
• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-18
• Last Update Submitted: 2021-08-18
• Study First Posted: 2021-08-24
• Last Update Posted: 2021-08-24
• Primary Completion: 2022-07-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional balloon predilation	Conventional Balloon	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
Scoring balloon predilation	Wedge Scoring Balloon	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

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon	Directly after procedure
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 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

Trial Locations

Locations (5)

CHU Ambroise Paré; 🇧🇪 Mons, Belgium

UZ Genk; 🇧🇪 Genk, Belgium

UZ Ghent; 🇧🇪 Ghent, Belgium

CHU Liège; 🇧🇪 Liège, Belgium

CHU Jolimont; 🇧🇪 La Louvière, Belgium