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

Stephane Carlier

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Device: Wedge Scoring Balloon; Device: Conventional Balloon

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05019443

007

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Conventional balloon predilation

Active Comparator group

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

Treatment:

Device: Conventional Balloon

Scoring balloon predilation

Experimental group

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

Treatment:

Device: Wedge Scoring Balloon