DynamX Bioadaptor Hong Kong Registry
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
DynamX Novolimus Eluting Coronary Bioadaptor System
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease focused on measuring drug eluting stent, percutaneous coronary intervention
Eligibility Criteria
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
Sites / Locations
- Kwong Wah Hospital
- Queen Elizabeth Hospital
- Queen Mary Hospital
- Chinese University of Hong Kong / Prince of Wales Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
DynamX Novolimus Eluting Coronary Bioadaptor System
Arm Description
DynamX use in de novo coronary artery lesions
Outcomes
Primary Outcome Measures
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
Device Oriented Clinical Endpoint
the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
Secondary Outcome Measures
Device Oriented Clinical Endpoint
the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
Device Oriented Clinical Endpoint
the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
death
cardiac and non-cardiac
death
cardiac and non-cardiac
death
cardiac and non-cardiac
myocardial infarction
target vessel and non-target vessel
myocardial infarction
target vessel and non-target vessel
myocardial infarction
target vessel and non-target vessel
target lesion revascularization
clinically-indicated
target lesion revascularization
clinically-indicated
target lesion revascularization
clinically-indicated
Full Information
NCT ID
NCT04483791
First Posted
July 16, 2020
Last Updated
April 13, 2023
Sponsor
Elixir Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04483791
Brief Title
DynamX Bioadaptor Hong Kong Registry
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elixir Medical Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
drug eluting stent, percutaneous coronary intervention
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-randomized, multicenter registry
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DynamX Novolimus Eluting Coronary Bioadaptor System
Arm Type
Other
Arm Description
DynamX use in de novo coronary artery lesions
Intervention Type
Combination Product
Intervention Name(s)
DynamX Novolimus Eluting Coronary Bioadaptor System
Other Intervention Name(s)
Novolimus, Bioadaptor
Intervention Description
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
Primary Outcome Measure Information:
Title
Acute Device Success
Description
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
procedure
Title
Device Oriented Clinical Endpoint
Description
the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Device Oriented Clinical Endpoint
Description
the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
Time Frame
1 month
Title
Device Oriented Clinical Endpoint
Description
the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
Time Frame
12 months
Title
death
Description
cardiac and non-cardiac
Time Frame
1 month
Title
death
Description
cardiac and non-cardiac
Time Frame
6 months
Title
death
Description
cardiac and non-cardiac
Time Frame
12 months
Title
myocardial infarction
Description
target vessel and non-target vessel
Time Frame
1 month
Title
myocardial infarction
Description
target vessel and non-target vessel
Time Frame
6 months
Title
myocardial infarction
Description
target vessel and non-target vessel
Time Frame
12 months
Title
target lesion revascularization
Description
clinically-indicated
Time Frame
1 month
Title
target lesion revascularization
Description
clinically-indicated
Time Frame
6 month
Title
target lesion revascularization
Description
clinically-indicated
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Kwong Wah Hospital
City
Hong Kong
State/Province
Kowloon
Country
China
Facility Name
Queen Elizabeth Hospital
City
Hong Kong
State/Province
Kowloon
Country
China
Facility Name
Queen Mary Hospital
City
Hong Kong
State/Province
Pok Fu Lam
Country
China
Facility Name
Chinese University of Hong Kong / Prince of Wales Hospital
City
Hong Kong
State/Province
Sha Tin
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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DynamX Bioadaptor Hong Kong Registry
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