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| Name | Class |
|---|---|
| BrosMed Medical Co., Ltd | INDUSTRY |
| University of Mons | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wedge Scoring Balloon | Device | Scoring balloon |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria patient-related:
Exclusion criteria lesion-related:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphane Carlier | Contact | 0032475812765 | stephane.carlier@umons.ac.be | |
| Chadi Ghafari | Contact | chadi.ghafari@umons.ac.be |
| Name | Affiliation | Role |
|---|---|---|
| Stéphane Carlier | University of Mons | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Genk | Recruiting | Genk | 3600 | Belgium |
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| Conventional Balloon |
| Device |
Conventional 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 |
| UZ Ghent | Recruiting | Ghent | 9000 | Belgium |
|
| CHU Jolimont | Recruiting | La Louvière | 7100 | Belgium |
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| CHU Liège | Recruiting | Liège | 4000 | Belgium |
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| CHU Ambroise Paré | Recruiting | Mons | 7000 | Belgium |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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