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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Scoring balloon
Conventional balloon
UZ Genk
Genk, Belgium
RECRUITINGUZ Ghent
Ghent, Belgium
RECRUITINGCHU Jolimont
La Louvière, Belgium
RECRUITINGCHU Liège
Liège, Belgium
RECRUITINGCHU Ambroise Paré
Mons, Belgium
RECRUITINGStent 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.
Time frame: Intravascular ultrasound (IVUS) or quantitative analysis is directly done after procedure
Rate of successful predilatation of calcified lesions of a scoring semi-compliant/non-compliant balloon and semi-compliant (SC)/ non-compliant (NC) balloon
Time frame: Directly after procedure
Rate of residual under-expansion of stent after post-dilatation with a non-compliant balloon
Time frame: 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.
Time frame: 1 month follow up
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