DESyne X2 Post Market Follow-up Study

Study Overview
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Brief Summary
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A single-arm post-market clinical follow-up study to confirm that the DESyne X2 delivery system performs similarly to the DESyne delivery system.

Detailed Description
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A single-arm post-market follow up study (PMCF) comparing the DESyne X2 PMCF data to the historic DESyne acute performance data to confirm the performance of the DESyne X2 Novolimus Eluting Coronary Stent System with regards to the residual risks of lesion access and acute device implantation through visually-assessed angiographic endpoints and physician feedback.

Official Title
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A Non-Randomized, Post Marketing Clinical Follow-Up (PMCF) Study of the DESyne X2 Novolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Percutaneous Coronary Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient must be ≥ 18 years of age. The patient must have stable angina pectoris as defined by the Canadian Cardiovascular Society Classification, documented silent ischemia, acute coronary syndrome, or a positive functional study requiring treatment The patient is considered a candidate for coronary stent implantation and has a planned intervention of up to two lesions located in separate major epicardial territories. Each lesion/vessel must meet the following criteria: De novo lesion The target lesion reference site must be visually estimated to be ≥ 2.5 mm and ≤ 4.0 mm in diameter The target vessel must be a major coronary artery or major branch with a visually estimated stenosis of ≥ 50% and < 100%. The visually estimated target lesion length must be ≤ 34 mm ≥ TIMI 1 coronary flow Exclusion Criteria: The patient has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor, heparin/bivalirudin, mTOR inhibitor class drugs, cobalt chromium alloy, methacrylate or polylactide polymer, or sensitivity to contrast which cannot be adequately premedicated Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing Previous placement of a stent within 10 mm distal to the target lesion Previous placement of a stent proximal to the target lesion Total occlusion or < TIMI 1 coronary flow in the target vessel The proximal target vessel or target lesion is severely calcified by visual assessment Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the left anterior descending or left circumflex Lesion involvement of a significant side branch (branch diameter > 2 mm) that would be covered by stenting High probability that treatment other than PTCA or stenting will be required for treatment of the same lesion The target lesion, or the target vessel proximal to the target lesion, contains thrombus The patient has suffered a myocardial infarction within the past 72 hours and the CK or CK-MB has not returned to normal at the time of the index procedure The patient is a recipient of a heart transplant The patient has extensive peripheral vascular disease that precludes safe sheath insertion or extreme anti-coagulation The patient is currently participating in another investigational device or drug study that has not completed the primary follow-up phase Patients who are unable or unwilling to cooperate with study procedures

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
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, non-randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DESyne X2 Novolimus Eluting Coronary Stent System<br> | Device: Percutaneous Coronary Intervention<br>* Percutaneous Coronary Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Success | attainment of final result with < 50% residual stenosis of the target site, using a DESyne X2 stent and standard pre-dilation catheters and post-dilatation catheters (if applicable) | during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician Assessment Was Performed After Each Case | A short questionnaire about device performance was included in the CRF. Device performance characteristics were rated on a scale of 1 to 5 (1 being poor performance and 5 being excellent performance). | Post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary stent, percutaneous coronary intervention