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Coronary Artery DiseasePhase 4NCT04483791

DynamX Bioadaptor Hong Kong Registry

A Phase 4 study testing DynamX Novolimus Eluting Coronary Bioadaptor System in people with Coronary Artery Disease, run by Elixir Medical Corporation at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective, non-randomized, multicenter registry Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
DynamX Novolimus Eluting Coronary Bioadaptor System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
4 sitesChina
Study dates
30 Sep 2020to 31 Dec 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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%

Who cannot join

  • 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)
Show all 21Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Kwong Wah Hospital

    Hong Kong, Kowloon

  • Queen Elizabeth Hospital

    Hong Kong, Kowloon

  • Queen Mary Hospital

    Hong Kong, Pok Fu Lam

  • Chinese University of Hong Kong / Prince of Wales Hospital

    Hong Kong, Sha Tin

Other trials in China

About this study

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

Prospective, non-randomized, multicenter registry

Read the 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

Being tested
DynamX Novolimus Eluting Coronary Bioadaptor System
Keywords
drug eluting stent, percutaneous coronary intervention
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DynamX Novolimus Eluting Coronary Bioadaptor SystemCombination product

    Also called Novolimus, Bioadaptor

    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

Study groups in NCT04483791
Study groupRoleWhat they receive
DynamX Novolimus Eluting Coronary Bioadaptor SystemOtherDynamX use in de novo coronary artery lesions
Receives: Combination Product: DynamX Novolimus Eluting Coronary Bioadaptor System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Immediately after final stent placement (intraprocedure)

  2. 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

    Measured: 12 Months

Secondary outcomes (11)

  1. 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

    Measured: 1 month

  2. Number of Participants With Cardiovascular and Non-Cardiovascular Death

    cardiac and non-cardiac

    Measured: 1 month

  3. Number of Participants With Cardiovascular and Non-Cardiovascular Death

    cardiac and non-cardiac

    Measured: 6 months

  4. Number of Participants With Cardiovascular and Non-Cardiovascular Death

    cardiac and non-cardiac

    Measured: 12 months

  5. Number of Participants With Myocardial Infarction

    target vessel and non-target vessel

    Measured: 1 month

  6. Number of Participants With Myocardial Infarction

    target vessel and non-target vessel

    Measured: 6 months

  7. Number of Participants With Myocardial Infarction

    target vessel and non-target vessel

    Measured: 12 months

  8. Number of Participants With Clinically-Indicated Target Lesion Revascularization

    clinically-indicated

    Measured: 1 month

  9. Number of Participants With Clinically-Indicated Target Lesion Revascularization

    clinically-indicated

    Measured: 6 month

  10. Number of Participants With Clinically-Indicated Target Lesion Revascularization

    clinically-indicated

    Measured: 12 month

  11. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2020
  2. Study start30 Sep 2020
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, non-randomized, multicenter registry
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04483791
Sponsor's protocol ID
ELX-CL-2001
Status last verified
Oct 2024
First submitted
16 Jul 2020
Last updated
17 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing DynamX Novolimus Eluting Coronary Bioadaptor System in people with Coronary Artery Disease, run by Elixir Medical Corporation at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute Device Success (time frame: Immediately after final stent placement (intraprocedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04483791.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.

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DynamX Bioadaptor Hong Kong Registry (NCT04483791) | AzTrials