Clinical trial NCT05019443: WEDGES: Coronary Lesion Preparation With Enhanced Dilatation for Good Expansion of Stent: Assessment of a New Scoring Balloon by Quantitative Stent Enhanced Visualization
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University of Mons
Sponsor class: OTHER
Collaborators: name: BrosMed Medical Co., Ltd
name: University of Mons
First posted: 2021-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Intravascular ultrasound (IVUS) or quantitative analysis is directly done after procedure
Secondary outcomes:
measure: Rate of successful predilatation of calcified lesions of a scoring semi-compliant/non-compliant balloon and semi-compliant (SC)/ non-compliant (NC) balloon
timeFrame: Directly after procedure
measure: Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon
timeFrame: Directly after procedure
measure: 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.
timeFrame: 1 month follow up
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: UZ Genk
city: Ghent
country: Belgium
facility: UZ Ghent
city: La Louvière
country: Belgium
facility: CHU Jolimont
city: Liège
country: Belgium
facility: CHU Liège
city: Mons
country: Belgium
facility: CHU Ambroise Paré
Study officials:
affiliation: University of Mons
name: Stéphane Carlier
role: STUDY_DIRECTOR
References: