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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Other | DynamX use in de novo coronary artery lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DynamX Novolimus Eluting Coronary Bioadaptor System | Combination Product | 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 |
| 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 | 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 | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
Target lesion / vessel specific
Patient specific:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kwong Wah Hospital | Hong Kong | Kowloon | China | |||
| Queen Elizabeth Hospital |
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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 (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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Immediately after final stent placement (intraprocedure) |
|
|
Through 12-months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedure Complications | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia requiring treatment | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Candace Elek, M.S. | EVP, Clinical Research | 408-913-5468 | celek@elixirmedical.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2020 | Oct 14, 2024 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C534800 | novolimus |
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Prospective, non-randomized, multicenter registry
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|
| Number of Participants With Cardiovascular and Non-Cardiovascular Death |
cardiac and non-cardiac |
| 1 month |
| Number of Participants With Cardiovascular and Non-Cardiovascular Death | cardiac and non-cardiac | 6 months |
| Number of Participants With Cardiovascular and Non-Cardiovascular Death | cardiac and non-cardiac | 12 months |
| Number of Participants With Myocardial Infarction | target vessel and non-target vessel | 1 month |
| Number of Participants With Myocardial Infarction | target vessel and non-target vessel | 6 months |
| Number of Participants With Myocardial Infarction | target vessel and non-target vessel | 12 months |
| Number of Participants With Clinically-Indicated Target Lesion Revascularization | clinically-indicated | 1 month |
| Number of Participants With Clinically-Indicated Target Lesion Revascularization | clinically-indicated | 6 month |
| Number of Participants With Clinically-Indicated Target Lesion Revascularization | clinically-indicated | 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 | 6 months |
| 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 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Hypercholesterolemia/Dyslipidemia | Count of Participants | Participants |
|
| Smoking (previous or current) | Count of Participants | Participants |
|
| Prior myocardial infarction (MI) | Count of Participants | Participants |
|
| Prior percutaneous coronary intervention | Count of Participants | Participants |
|
| Stable angina | Count of Participants | Participants |
|
| Unstable angina | Count of Participants | Participants |
|
| ST Elevation MI | Count of Participants | Participants |
|
| Non-ST Elevation MI | Count of Participants | Participants |
|
| Silent ischemia / Asymptomatic | Count of Participants | Participants |
|
| 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 | 49 out of 50 participants enrolled were evaluated at the 12-month visit related to 1 lost to follow-up. | Posted | Count of Participants | Participants | 12 Months |
|
|
|
| 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 | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Number of Participants With Cardiovascular and Non-Cardiovascular Death | cardiac and non-cardiac | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Number of Participants With Cardiovascular and Non-Cardiovascular Death | cardiac and non-cardiac | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants With Cardiovascular and Non-Cardiovascular Death | cardiac and non-cardiac | 49 out of 50 participants enrolled were evaluated at the 12-month visit related to 1 lost to follow-up. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants With Myocardial Infarction | target vessel and non-target vessel | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Number of Participants With Myocardial Infarction | target vessel and non-target vessel | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Number of Participants With Myocardial Infarction | target vessel and non-target vessel | 49 out of 50 participants enrolled were evaluated at the 12-month visit related to 1 lost to follow-up. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Number of Participants With Clinically-Indicated Target Lesion Revascularization | clinically-indicated | Posted | Count of Participants | Participants | 1 month |
|
|
|
| Secondary | Number of Participants With Clinically-Indicated Target Lesion Revascularization | clinically-indicated | Posted | Count of Participants | Participants | 6 month |
|
|
|
| Secondary | Number of Participants With Clinically-Indicated Target Lesion Revascularization | clinically-indicated | 49 out of 50 participants enrolled were evaluated at the 12-month visit related to 1 lost to follow-up. | Posted | Count of Participants | Participants | 12 month |
|
|
|
| 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 | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 50 |
| 30 |
| 50 |
| 6 |
| 50 |
| Arrhythmia requiring treatment | Cardiac disorders | Systematic Assessment |
|
| Recurrent ischemia/chest pain | Cardiac disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Hypotension/Syncope | Cardiac disorders | Systematic Assessment |
|
| Chest Infection | Infections and infestations | Systematic Assessment |
|
| Bleeding Complications/Hematoma | General disorders | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Extremity Pain/Injury | General disorders | Systematic Assessment |
|
| Renal/UT Events | Renal and urinary disorders | Systematic Assessment |
|
| Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Recurrent Ischemia/Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Bleeding complications/hematoma | General disorders | Systematic Assessment |
|
| Other non-cardiac events | General disorders | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |