Coronary Artery Disease
Conditions
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
Interventions
DEVICEWedge Scoring Balloon
Scoring balloon
DEVICEConventional Balloon
Conventional balloon
Sponsors
BrosMed Medical Co., Ltd
University of Mons
Stephane Carlier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium
Contacts
Primary ContactStéphane Carlier
Backup ContactChadi Ghafari
Outcome results
None listed