Coronary Artery Disease
Conditions
Keywords
drug eluting stent, percutaneous coronary intervention
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 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
Interventions
COMBINATION_PRODUCTDynamX Novolimus Eluting Coronary Bioadaptor System
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
Sponsors
Elixir Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective, non-randomized, multicenter registry
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subject age ≥ 18 and ≤ 80 years 2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment 3. 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) 4. Vessel diameter (2.25-3.5 mm) and lesions length ≤ 34 mm suitable for implantation using a single stent per lesion 5. All lesions requiring PCI should be amendable for implantation with the study stent 6. 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
1. Target lesion / vessel specific 1. Lesions in the left main 2. Venous or arterial bypass grafts 3. In-stent restenosis 4. Chronic total occlusion 5. Ostial lesions (\< 3 mm from the ostium of the RCA, LAD or Cx) 6. Stent implanted \< 10 mm from the target lesion in the previous 30 days. 7. Lesion requiring rotablation or atherectomy because of, but not limited to severe calcification 8. Bifurcation lesions requiring a planned 2 or more stent technique 2. Patient specific: 1. STEMI 2. Acute myocardial infarction with Killip Class III and IV 3. Known LVEF \< 30% 4. Life expectancy \< 1 year 5. Patients on renal dialysis or known GFR \< 30 ml/min 3. Planned surgery necessitating interruption of dual antiplatelet therapy within the first 6 months 4. Known intolerance to components of the investigational product or medication required (e.g. intolerance to concomitant anticoagulation or antiplatelet therapy) 5. Subject is receiving or will require chronic anticoagulation therapy (e.g. coumadin, dabigatran, apixaban, rivaroxaban, edoxaban or low molecular weight heparin) 6. Subject is currently participating in another clinical trial with an investigational drug or device that has not yet completed its primary endpoint 7. Known pregnancy or breastfeeding 8. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Device Success | Immediately after final stent placement (intraprocedure) | 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 |
| Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR). | 12 Months | the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR). | 1 month | the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization |
| Number of Participants With Cardiovascular and Non-Cardiovascular Death | 1 month | cardiac and non-cardiac |
| Number of Participants With Myocardial Infarction | 1 month | target vessel and non-target vessel |
| Number of Participants With Clinically-Indicated Target Lesion Revascularization | 1 month | clinically-indicated |
Countries
China
Participant flow
Recruitment details
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 (CBS), 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 device.
Participants by arm
| Arm | Count |
|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System DynamX use in de novo coronary artery lesions
DynamX Novolimus Eluting Coronary Bioadaptor System: 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 | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | DynamX Novolimus Eluting Coronary Bioadaptor System | — |
|---|---|---|
| Age, Continuous | 64 Years STANDARD_DEVIATION 9.7 | — |
| Diabetes Mellitus | 18 Participants | — |
| Hypercholesterolemia/Dyslipidemia | 46 Participants | — |
| Hypertension | 39 Participants | — |
| Non-ST Elevation MI | 4 Participants | — |
| Prior myocardial infarction (MI) | 6 Participants | — |
| Prior percutaneous coronary intervention | 9 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Hong Kong | 50 Participants | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 41 Participants | — |
| Silent ischemia / Asymptomatic | 4 Participants | — |
| Smoking (previous or current) | 29 Participants | — |
| Stable angina | 20 Participants | — |
| ST Elevation MI | 2 Participants | — |
| Unstable angina | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 6 / 50 |
| serious Total, serious adverse events | 30 / 50 |
Outcome results
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Acute Device Success | 49 Participants |
Primary
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
Population: 49 out of 50 participants enrolled were evaluated at the 12-month visit related to 1 lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR). | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR). | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Device Oriented Clinical Endpoint; Number of Participants With Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) or Clinically-Driven Target Lesion Revascularization (CD-TLR). | 0 Participants |
Secondary
Number of Participants With Cardiovascular and Non-Cardiovascular Death
cardiac and non-cardiac
Time frame: 12 months
Population: 49 out of 50 participants enrolled were evaluated at the 12-month visit related to 1 lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Number of Participants With Cardiovascular and Non-Cardiovascular Death | 0 Participants |
Secondary
Number of Participants With Cardiovascular and Non-Cardiovascular Death
cardiac and non-cardiac
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Number of Participants With Cardiovascular and Non-Cardiovascular Death | 0 Participants |
Secondary
Number of Participants With Cardiovascular and Non-Cardiovascular Death
cardiac and non-cardiac
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Number of Participants With Cardiovascular and Non-Cardiovascular Death | 0 Participants |
Secondary
Number of Participants With Clinically-Indicated Target Lesion Revascularization
clinically-indicated
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Number of Participants With Clinically-Indicated Target Lesion Revascularization | 0 Participants |
Secondary
Number of Participants With Clinically-Indicated Target Lesion Revascularization
clinically-indicated
Time frame: 6 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Number of Participants With Clinically-Indicated Target Lesion Revascularization | 0 Participants |
Secondary
Number of Participants With Clinically-Indicated Target Lesion Revascularization
clinically-indicated
Time frame: 12 month
Population: 49 out of 50 participants enrolled were evaluated at the 12-month visit related to 1 lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Number of Participants With Clinically-Indicated Target Lesion Revascularization | 0 Participants |
Secondary
Number of Participants With Myocardial Infarction
target vessel and non-target vessel
Time frame: 1 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Number of Participants With Myocardial Infarction | 0 Participants |
Secondary
Number of Participants With Myocardial Infarction
target vessel and non-target vessel
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Number of Participants With Myocardial Infarction | 0 Participants |
Secondary
Number of Participants With Myocardial Infarction
target vessel and non-target vessel
Time frame: 12 months
Population: 49 out of 50 participants enrolled were evaluated at the 12-month visit related to 1 lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Number of Participants With Myocardial Infarction | 0 Participants |