DynamX Bioadaptor Hong Kong Registry

Study Overview
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Brief Summary
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Prospective, non-randomized, multicenter registry

Detailed Description
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Enrollment of up to 50 subjects with up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and<=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System (CSS), with primary, interim clinical follow-up via telephone at 1 month. Follow-up will continue at 6, and 12 months. to capture cardiovascular related hospitalizations related to the study devic

Official Title
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A Non-Randomized, Clinical Registry of the Dynamx Novolimus Eluting Coronary Bioadaptor 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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* Combination Product: DynamX Novolimus Eluting Coronary Bioadaptor System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject age ≥ 18 and ≤ 80 years Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment Indication for a percutaneous intervention with stent implantation in native epicardial arteries including patients with stable coronary artery disease and acute coronary syndromes (non-ST-elevated myocardial infarction) Vessel diameter (2.25-3.5 mm) and lesions length ≤ 34 mm suitable for implantation using a single stent per lesion All lesions requiring PCI should be amendable for implantation with the study stent Successful pre-dilatation of the first lesion defined as no waist in the inflated pre-dilatation balloon using two orthogonal views using a pre- dilatation balloon diameter size ranging from the reference vessel diameter to 0.25 mm smaller than the reference vessel diameter, and a residual diameter stenosis prior to study device implantation by visual estimate being < 35% Exclusion Criteria: Target lesion / vessel specific Lesions in the left main Venous or arterial bypass grafts In-stent restenosis Chronic total occlusion Ostial lesions (< 3 mm from the ostium of the RCA, LAD or Cx) Stent implanted < 10 mm from the target lesion in the previous 30 days. Lesion requiring rotablation or atherectomy because of, but not limited to severe calcification Bifurcation lesions requiring a planned 2 or more stent technique Patient specific: STEMI Acute myocardial infarction with Killip Class III and IV Known LVEF < 30% Life expectancy < 1 year Patients on renal dialysis or known GFR < 30 ml/min Planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months Known intolerance to components of the investigational product or medication required (e.g. intolerance to concomitant anticoagulation or antiplatelet therapy) Subject is receiving or will require chronic anticoagulation therapy (e.g. coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or low molecular weight heparin) Subject is currently participating in another clinical trial with an investigational drug or device that has not yet completed its primary endpoint Known pregnancy or breastfeeding Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, non-randomized, multicenter registry
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DynamX Novolimus Eluting Coronary Bioadaptor System<br>DynamX use in de novo coronary artery lesions | Combination Product: DynamX Novolimus Eluting Coronary Bioadaptor System<br>* up to two de novo native coronary artery lesions measuring between 2.25 and 3.5 mm in diameter and<=34 mm in length receiving the DynamX Novolimus Eluting Coronary Bioadaptor System<br>* Other names: Bioadaptor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Device Success | Percentage of patients with an attainment of a final result of < 30% residual stenosis using the DynamX bioadaptor with standard pre-dilatation and post-dilatation (if applicable) catheters | procedure | 
| Device Oriented Clinical Endpoint | the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Oriented Clinical Endpoint | the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization | 1 month | 
| Device Oriented Clinical Endpoint | the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization | 12 months | 
| death | cardiac and non-cardiac | 1 month | 
| death | cardiac and non-cardiac | 6 months | 
| death | cardiac and non-cardiac | 12 months | 
| myocardial infarction | target vessel and non-target vessel | 1 month | 
| myocardial infarction | target vessel and non-target vessel | 6 months | 
| myocardial infarction | target vessel and non-target vessel | 12 months | 
| target lesion revascularization | clinically-indicated | 1 month | 
| target lesion revascularization | clinically-indicated | 6 month | 
| target lesion revascularization | clinically-indicated | 12 month | 

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