Status:
COMPLETED
DynamX Bioadaptor Hong Kong Registry
Lead Sponsor:
Elixir Medical Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Prospective, non-randomized, multicenter registry
Detailed Description
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 Coronar...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04483791
Start Date
September 30 2020
End Date
December 31 2022
Last Update
October 17 2024
Active Locations (4)
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1
Kwong Wah Hospital
Hong Kong, Kowloon, China
2
Queen Elizabeth Hospital
Hong Kong, Kowloon, China
3
Queen Mary Hospital
Hong Kong, Pok Fu Lam, China
4
Chinese University of Hong Kong / Prince of Wales Hospital
Hong Kong, Sha Tin, China