Prospective, non-randomized, multicenter registry
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
50
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
Kwong Wah Hospital
Hong Kong, Kowloon, China
Queen Elizabeth Hospital
Hong Kong, Kowloon, China
Queen Mary Hospital
Hong Kong, Pok Fu Lam, China
Chinese University of Hong Kong / Prince of Wales Hospital
Hong Kong, Sha Tin, China
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
Time frame: Immediately after final stent placement (intraprocedure)
Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).
the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
Time frame: 12 Months
Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).
the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
Time frame: 1 month
Number of Participants With Cardiovascular and Non-Cardiovascular Death
cardiac and non-cardiac
Time frame: 1 month
Number of Participants With Cardiovascular and Non-Cardiovascular Death
cardiac and non-cardiac
Time frame: 6 months
Number of Participants With Cardiovascular and Non-Cardiovascular Death
cardiac and non-cardiac
Time frame: 12 months
Number of Participants With Myocardial Infarction
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target vessel and non-target vessel
Time frame: 1 month
Number of Participants With Myocardial Infarction
target vessel and non-target vessel
Time frame: 6 months
Number of Participants With Myocardial Infarction
target vessel and non-target vessel
Time frame: 12 months
Number of Participants With Clinically-Indicated Target Lesion Revascularization
clinically-indicated
Time frame: 1 month
Number of Participants With Clinically-Indicated Target Lesion Revascularization
clinically-indicated
Time frame: 6 month
Number of Participants With Clinically-Indicated Target Lesion Revascularization
clinically-indicated
Time frame: 12 month
Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR).
the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
Time frame: 6 months