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

NCT05019443 | Unknown DMC

• 1 other identifier: 007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Conventional balloon predilation

ACTIVE COMPARATOR

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

Scoring balloon predilation

EXPERIMENTAL

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

Interventions

Wedge Scoring Balloon DEVICE

Scoring balloon

Scoring balloon predilation

Conventional Balloon DEVICE

Conventional balloon

Conventional balloon predilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient written consent is given A de novo lesion
• Mild to moderate burden of calcifications detected on two orthogonal views using normal radiation power

You may not qualify if:

• Patient \<18 years old
• Pregnant female
• Contraindication to dual antiplatelet therapy
• Thrombocytopenia \<100 000
• Major surgical intervention planned
• 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

Sponsors & Collaborators

• Stephane Carlier: lead
• BrosMed Medical Co., Ltd: collaborator
• University of Mons: collaborator

Study Sites (5)

UZ Genk

Genk, 3600, Belgium

RECRUITING

UZ Ghent

Ghent, 9000, Belgium

RECRUITING

CHU Jolimont

La Louvière, 7100, Belgium

RECRUITING

CHU Liège

Liège, 4000, Belgium

RECRUITING

CHU Ambroise Paré

Mons, 7000, Belgium

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Stéphane Carlier

  University of Mons

  STUDY DIRECTOR

Central Study Contacts

Stéphane Carlier

CONTACT

0032475812765; stephane.carlier@umons.ac.be

Chadi Ghafari

CONTACT

chadi.ghafari@umons.ac.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 24, 2021
• Study Start: January 1, 2020
• Primary Completion: July 30, 2022
• Study Completion: October 30, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5)