Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent

Study Overview
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Brief Summary
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The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.

Official Title
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SeQuent 1000 - Treatment of Coronary Artery Disease With Bare Metal Stent Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent: Randomized Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB)
* Device: Coroflex Please (DES)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina and silent ischemia Presence of one or more coronary artery stenosis >50% in a native coronary artery from 2.25 to 3.5 mm in diameter that can be covered with one stent One lesion treated with the study device Exclusion Criteria: Pregnancy Known intolerance to aspirin, clopidogrel, heparin, stainless steel, paclitaxel, cobalt, chromium or contrast material Inability to provide informed consent Currently participating in another trial before reaching the primary endpoint Elective surgery within 12 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri-surgical period Acute or recent myocardial infarction left ventricular ejection fraction (LVEF) < 30 % Stroke or transient ischemic attack within 6 months Stented segment longer than 23 mm Vessel diameter of less than 2,5 mm Significant calcification, chronic total occlusion (CTO) or thrombus in the target lesion

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB)<br> | Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB)<br>* standard techniques will be used maximal vasodilatation after nitro application baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap) 6 French guiding catheter at least target lesion will be crossed with standard guidewire direct stenting at the discretion of the investigator if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted) full lesion coverage will be ensured (with one or more stents) only insert assigned stent type BMS needs to be fully embedded in vessel wall post-dilation with high pressure is required before treatment with DEB DEB will be inflated with nominal pressure (balloon equates to vessel diameter) length of DEB should exceed the BMS by 2-3 mm on each side if dissection, full length of dissection and optional additional stented area should be treated with additional DEB (to avoid geographic miss)<br>* Other names: DEB;|
| Active Comparator: Drug Eluting Stent (DES)<br> | Device: Coroflex Please (DES)<br>* standard techniques will be used maximal vasodilatation after nitro application baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap) 6 French guiding catheter at least target lesion will be crossed with standard guidewire direct stenting at the discretion of the investigator if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted) full lesion coverage will be ensured (with one or more stents) only insert assigned stent type<br>* Other names: DES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events (MACE) - target vessel failure (TVF) | consisting of the composite of cardiac death, myocardial infarction (Q-wave and Non-Q wave) localized at the territory supplied by the treated vessel or target vessel revascularization (TVR) by either percutaneous coronary intervention or bypass graft surgery in the overall population | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events (MACE) | defined as the composite of cardiovascular death, stroke, myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR), as well as the individual components of target vessel revascularization (TVR) and Major adverse cardiac events (MACE) and stent thrombosis | 1 year | 
| in-stent binary restenosis | defined as >= 50 % diameter stenosis (% DS) | 9 months | 
| Angiographic and clinical stent thrombosis |  | 30 days | 
| Angiographic and clinical stent thrombosis |  | 6 months | 
| Angiographic and clinical stent thrombosis |  | 9 months | 
| Angiographic and clinical stent thrombosis |  | 1 year | 
| Angiographic and clinical stent thrombosis |  | 2 years | 
| Angiographic and clinical stent thrombosis |  | 3 years | 
| In-stent and in-segment minimal luminal diameter (MLD) |  | 9 months | 
| In-segment percent diameter stenosis (%DS) |  | 9 months | 
| In-stent and in-segment late luminal loss |  | 9 months |