Trial Outcomes & Findings for DynamX Bioadaptor Hong Kong Registry (NCT NCT04483791)
NCT ID: NCT04483791
Last Updated: 2024-10-17
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Immediately after final stent placement (intraprocedure)
Results posted on
2024-10-17
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=50 Participants
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
|
|---|---|
|
Age, Continuous
|
64 Years
STANDARD_DEVIATION 9.7 • n=50 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=50 Participants
|
|
Region of Enrollment
Hong Kong
|
50 Participants
n=50 Participants
|
|
Diabetes Mellitus
|
18 Participants
n=50 Participants
|
|
Hypertension
|
39 Participants
n=50 Participants
|
|
Hypercholesterolemia/Dyslipidemia
|
46 Participants
n=50 Participants
|
|
Smoking (previous or current)
|
29 Participants
n=50 Participants
|
|
Prior myocardial infarction (MI)
|
6 Participants
n=50 Participants
|
|
Prior percutaneous coronary intervention
|
9 Participants
n=50 Participants
|
|
Stable angina
|
20 Participants
n=50 Participants
|
|
Unstable angina
|
20 Participants
n=50 Participants
|
|
ST Elevation MI
|
2 Participants
n=50 Participants
|
|
Non-ST Elevation MI
|
4 Participants
n=50 Participants
|
|
Silent ischemia / Asymptomatic
|
4 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=50 Participants
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
|
|---|---|
|
Acute Device Success
|
49 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: 49 out of 50 participants enrolled were evaluated at the 12-month visit related to 1 lost to follow-up.
the composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=49 Participants
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
|
|---|---|
|
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 outcome
Timeframe: 1 monththe composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=50 Participants
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
|
|---|---|
|
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 outcome
Timeframe: 1 monthcardiac and non-cardiac
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=50 Participants
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
|
|---|---|
|
Number of Participants With Cardiovascular and Non-Cardiovascular Death
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthscardiac and non-cardiac
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=50 Participants
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
|
|---|---|
|
Number of Participants With Cardiovascular and Non-Cardiovascular Death
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 49 out of 50 participants enrolled were evaluated at the 12-month visit related to 1 lost to follow-up.
cardiac and non-cardiac
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=49 Participants
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
|
|---|---|
|
Number of Participants With Cardiovascular and Non-Cardiovascular Death
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 monthtarget vessel and non-target vessel
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=50 Participants
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
|
|---|---|
|
Number of Participants With Myocardial Infarction
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthstarget vessel and non-target vessel
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=50 Participants
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
|
|---|---|
|
Number of Participants With Myocardial Infarction
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 49 out of 50 participants enrolled were evaluated at the 12-month visit related to 1 lost to follow-up.
target vessel and non-target vessel
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=49 Participants
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
|
|---|---|
|
Number of Participants With Myocardial Infarction
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 monthclinically-indicated
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=50 Participants
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
|
|---|---|
|
Number of Participants With Clinically-Indicated Target Lesion Revascularization
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthclinically-indicated
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=50 Participants
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
|
|---|---|
|
Number of Participants With Clinically-Indicated Target Lesion Revascularization
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthPopulation: 49 out of 50 participants enrolled were evaluated at the 12-month visit related to 1 lost to follow-up.
clinically-indicated
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=49 Participants
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
|
|---|---|
|
Number of Participants With Clinically-Indicated Target Lesion Revascularization
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsthe composite of cardiovascular death, target vessel myocardial infarction or clinically-driven target lesion revascularization
Outcome measures
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=50 Participants
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
|
|---|---|
|
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
|
Adverse Events
DynamX Novolimus Eluting Coronary Bioadaptor System
Serious events: 30 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=50 participants at risk
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
|
|---|---|
|
Injury, poisoning and procedural complications
Procedure Complications
|
6.0%
3/50 • Through 12-months
|
|
Cardiac disorders
Arrhythmia requiring treatment
|
10.0%
5/50 • Through 12-months
|
|
Cardiac disorders
Recurrent ischemia/chest pain
|
10.0%
5/50 • Through 12-months
|
|
Cardiac disorders
Hypertension
|
4.0%
2/50 • Through 12-months
|
|
Cardiac disorders
Hypotension/Syncope
|
4.0%
2/50 • Through 12-months
|
|
Infections and infestations
Chest Infection
|
2.0%
1/50 • Through 12-months
|
|
General disorders
Bleeding Complications/Hematoma
|
2.0%
1/50 • Through 12-months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
14.0%
7/50 • Through 12-months
|
|
General disorders
Extremity Pain/Injury
|
4.0%
2/50 • Through 12-months
|
|
Renal and urinary disorders
Renal/UT Events
|
2.0%
1/50 • Through 12-months
|
|
Cardiac disorders
Heart Failure
|
2.0%
1/50 • Through 12-months
|
Other adverse events
| Measure |
DynamX Novolimus Eluting Coronary Bioadaptor System
n=50 participants at risk
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
|
|---|---|
|
Cardiac disorders
Arrhythmia requiring treatment
|
2.0%
1/50 • Through 12-months
|
|
Cardiac disorders
Recurrent Ischemia/Chest Pain
|
4.0%
2/50 • Through 12-months
|
|
Cardiac disorders
Hypertension
|
2.0%
1/50 • Through 12-months
|
|
General disorders
Bleeding complications/hematoma
|
2.0%
1/50 • Through 12-months
|
|
General disorders
Other non-cardiac events
|
2.0%
1/50 • Through 12-months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place