Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation in Patients With Diabetes Mellitus (CUT-DRESS).

Study Overview
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Brief Summary
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Diabetes mellitus is one of the most important diseases worldwide. Patients with diabetes mellitus, as compared to those without, present a more diffuse, progressive coronary artery disease with smaller lumen dimensions leading to suboptimal outcomes after PCI and increased risk of restenosis and adverse cardiac events. Lesion pre-dilation prior to DES implantation is a crucial procedural step as it creates microdissections, which are required for optimal uptake of the drug. However, the best pre-dilation strategy has not yet been determined. Therefore, the aim of this study is to evaluate a strategy based on pre-dilation with cutting balloon (CB) followed by Abluminus Sirolimus-eluting stent (ASES) implantation for de novo coronary lesions in patients at high risk of restenosis.

Detailed Description
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The study will be a prospective, multicenter, randomized controlled trial in patients with diabetes mellitus undergoing PCI with the novo coronary disease. A total of 96 diabetic patients with de novo coronary artery stenosis will be included. After being informed about the study and the potential risks, all patients meeting all the inclusion criteria and none of exclusion criteria will give written informed consent. Random allocation in a 1:1 fashion to one of the following strategies: A) Study group: Pre-dilation with cutting balloon followed by ASES implantation. B) Control group: Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation. Stent optimisation will be performed based on intracoronary imaging findings.

Official Title
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Cutting Balloon Predilation Prior to Abluminus Sirolimus-eluting Stent Implantation in Patients With Diabetes Mellitus

Conditions
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Diabetes Mellitus, Coronary Artery Disease, Percutaneous Coronary Intervention, Cutting Balloon

Intervention / Treatment
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* Device: Predilation with cutting balloon.
* Device: Predilation with conventional balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetic patients Symptomatic coronary artery disease or evidence of ischemia in the presence of one or more coronary artery stenoses >50% in a native coronary artery. Exclusion Criteria: Cardiogenic shock Patients presenting with ST-segment elevation myocardial infarction Patients undergoing chronic total occlusions PCI Patients undergoing left main PCI Patients undergoing venous bypass graft lesions PCI Patients with in-stent restenosis Inability to provide informed consent Life expectancy <1year due to non-cardiac disease Currently participating in another trial before reaching first endpoint There will be no exclusion based on mode of co-morbidities, left ventricular function, number of diseased vessels and lesions, or number of target lesions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, multicenter, randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>Pre-dilation with cutting balloon followed by ASES implantation. | Device: Predilation with cutting balloon.<br>* PCI will be performed under OCT guidance. Predilation of the lesion will be done with cutting balloon.<br>* Other names: Wolverine Cutting balloon;|
| Active Comparator: Control group<br>Pre-dilation with a standard balloon (semi-compliant or non-compliant) followed by ASES implantation. | Device: Predilation with conventional balloon<br>* PCI will be performed under OCT guidance. Predilation of the lesion will be done with conventional balloon (semi-compliant or non-compliant)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimum stent area post-stenting measured by optimal coherence tomography (OCT) |  | Immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of neointimal hyperplasia (%) measured by OCT coherence tomography (OCT). | Key secondary | 9 month follow-up. | 
| Mean stent area measured by optimal coherence tomography |  | 9 month follow-up. | 
| Acute procedural success |  | Immediately after the procedure | 
| Coronary disection |  | Immediately after the procedure | 
| Malapposition (Major/minor) post-stenting measured by optimal coherence tomography |  | Immediately after the procedure and at 9 month follow-up | 
| Mean neointimal hyperplasia area measured by optimal coherence tomography |  | 9 months | 
| Minimum stent eccentricity measured by optimal coherence tomography |  | 9 months | 
| Stent asymmetry index measured by optimal coherence tomography |  | 9 months | 
| All cause death |  | 12 months | 
| Death from cardiovascular causes |  | 12 months | 
| Target vessel myocardial infarction |  | 12 months | 
| Target lesion revascularization |  | 12 months | 
| Stent thrombosis |  | 12 months | 
| Any myocardial infarction |  | 12 months |