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

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

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

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