Coronary Artery DiseaseNCT04375085

DESyne X2 Post Market Follow-up Study

A study testing Percutaneous Coronary Intervention in people with Coronary Artery Disease, run by Elixir Medical Corporation at 3 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A single-arm post-market clinical follow-up study to confirm that the DESyne X2 delivery system performs similarly to the DESyne delivery system. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Percutaneous Coronary Intervention
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 3 sitesChina
Study dates: 1 Sep 2020to 28 Dec 2021
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patient must be ≥ 18 years of age.
The patient must have stable angina pectoris as defined by the Canadian Cardiovascular Society Classification, documented silent ischemia, acute coronary syndrome, or a positive functional study requiring treatment
The patient is considered a candidate for coronary stent implantation and has a planned intervention of up to two lesions located in separate major epicardial territories. Each lesion/vessel must meet the following criteria:
De novo lesion
The target lesion reference site must be visually estimated to be ≥ 2.5 mm and ≤ 4.0 mm in diameter
The target vessel must be a major coronary artery or major branch with a visually estimated stenosis of ≥ 50% and < 100%.
The visually estimated target lesion length must be ≤ 34 mm
≥ TIMI 1 coronary flow

Who cannot join

The patient has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor, heparin/bivalirudin, mTOR inhibitor class drugs, cobalt chromium alloy, methacrylate or polylactide polymer, or sensitivity to contrast which cannot be adequately premedicated
Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing
Previous placement of a stent within 10 mm distal to the target lesion
Previous placement of a stent proximal to the target lesion
Total occlusion or < TIMI 1 coronary flow in the target vessel
The proximal target vessel or target lesion is severely calcified by visual assessment

Show all 15Show fewer

Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the left anterior descending or left circumflex
Lesion involvement of a significant side branch (branch diameter > 2 mm) that would be covered by stenting
High probability that treatment other than PTCA or stenting will be required for treatment of the same lesion
The target lesion, or the target vessel proximal to the target lesion, contains thrombus
The patient has suffered a myocardial infarction within the past 72 hours and the CK or CK-MB has not returned to normal at the time of the index procedure
The patient is a recipient of a heart transplant
The patient has extensive peripheral vascular disease that precludes safe sheath insertion or extreme anti-coagulation
The patient is currently participating in another investigational device or drug study that has not completed the primary follow-up phase
Patients who are unable or unwilling to cooperate with study procedures

Trial locations and contacts

3 sites in 1 country.

China3 sites

Kwong Wah Hospital
Hong Kong, Kowloon
Queen Elizabeth Hospital
Hong Kong, Kowloon
Tseung Kwan O Hospital
Hong Kong

Other trials in China

About this study

Official title: A Non-Randomized, Post Marketing Clinical Follow-Up (PMCF) Study of the DESyne X2 Novolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions

A single-arm post-market clinical follow-up study to confirm that the DESyne X2 delivery system performs similarly to the DESyne delivery system.

Read the detailed description

A single-arm post-market follow up study (PMCF) comparing the DESyne X2 PMCF data to the historic DESyne acute performance data to confirm the performance of the DESyne X2 Novolimus Eluting Coronary Stent System with regards to the residual risks of lesion access and acute device implantation through visually-assessed angiographic endpoints and physician feedback.

Conditions: Coronary Artery Disease
Being tested: Percutaneous Coronary Intervention
Keywords: coronary 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.

Percutaneous Coronary InterventionDevice
Percutaneous Coronary Intervention

Study groups in NCT04375085
Study group	Role	What they receive
DESyne X2 Novolimus Eluting Coronary Stent System	Other	Not described Receives: Device: Percutaneous Coronary Intervention

What is being measured

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

Acute Success
attainment of final result with < 50% residual stenosis of the target site, using a DESyne X2 stent and standard pre-dilation catheters and post-dilatation catheters (if applicable)
Measured: during procedure

Secondary outcomes (1)

Physician Assessment Was Performed After Each Case
A short questionnaire about device performance was included in the CRF. Device performance characteristics were rated on a scale of 1 to 5 (1 being poor performance and 5 being excellent performance).
Measured: Post procedure

Timeline

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

1 Sep 202028 Dec 2021

First posted5 May 2020
Study start1 Sep 2020
Primary completion28 Dec 2021
Study completion28 Dec 2021

Why it stopped: Enrollment was delayed and could not be completed as planned

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective, non-randomized
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04375085
Sponsor's protocol ID: ELX-CL-1705
Status last verified: Oct 2023
First submitted: 29 Apr 2020
Last updated: 25 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-Randomized, Post Marketing Clinical Follow-Up (PMCF) Study of the DESyne X2 Novolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions
ClinicalTrials.gov ID: NCT04375085
Acronym / sponsor ID: ELX-CL-1705
Conditions: Coronary Artery Disease
Keywords: coronary stent, percutaneous coronary intervention
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment was delayed and could not be completed as planned
Enrolment: 49 participants (actual)
Lead sponsor: Elixir Medical CorporationIndustry (pharma, biotech, devices)
Study start: 1 Sep 2020 (actual)
Primary completion: 28 Dec 2021 (actual)
Study completion: 28 Dec 2021 (actual)
First posted: 5 May 2020 (actual)
Results: Posted 25 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A single-arm post-market clinical follow-up study to confirm that the DESyne X2 delivery system performs similarly to the DESyne delivery system.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective, non-randomized

Arm	Type	Receives
DESyne X2 Novolimus Eluting Coronary Stent System	Other	Device: Percutaneous Coronary Intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

The patient must be ≥ 18 years of age.
The patient must have stable angina pectoris as defined by the Canadian Cardiovascular Society Classification, documented silent ischemia, acute coronary syndrome, or a positive functional study requiring treatment
The patient is considered a candidate for coronary stent implantation and has a planned intervention of up to two lesions located in separate major epicardial territories. Each lesion/vessel must meet the following criteria:

Key exclusion criteria (15 listed)

The patient has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor, heparin/bivalirudin, mTOR inhibitor class drugs, cobalt chromium alloy, methacrylate or polylactide polymer, or sensitivity to contrast which cannot be adequately premedicated
Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing
Previous placement of a stent within 10 mm distal to the target lesion
Previous placement of a stent proximal to the target lesion
Total occlusion or < TIMI 1 coronary flow in the target vessel

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Percutaneous Coronary InterventionPercutaneous Coronary Intervention	Device	DESyne X2 Novolimus Eluting Coronary Stent System

Primary outcome

Acute Success
Time frame: during procedure
attainment of final result with < 50% residual stenosis of the target site, using a DESyne X2 stent and standard pre-dilation catheters and post-dilatation catheters (if applicable)

1 secondary outcome

Physician Assessment Was Performed After Each Case
Time frame: Post procedure

Results and safety

Results posted to the registry on 25 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DESyne X2 Novolimus Eluting Coronary Stent System	49	49

Primary outcome: Acute Success

Time frame: during procedure. Count of participants. Unit: Participants

Measure	Acute Success n = 49
Value	49

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Peri-procedurally. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Receiving the DESyne X2 Coronary Stent	0 of 49 (0%)	3 of 49 (6.1%)	0 of 49

Limitations and caveats (from the sponsor): The study was halted early with enrollment of 49 of the planned 100 patients due to slow enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Coronary Artery Disease

Not yet recruiting
GOT VOICE Feasibility With In-Person Group Singing
Elderly, Coronary Arterial Disease (CAD)
RecruitingObservational study
Real-life Registry in Patients With Coronary Artery Disease Treated With the SELUTION Sirolimus-eluting Balloon. Selution Iberia Registry
Cardiovascular Diseases
Recruiting
Lifewise Preventive Video Education in Primary Care
Prevention Harmful Effects, Health Maintenance
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
Active, not recruiting
Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Coronary Intervention in people with Coronary Artery Disease, run by Elixir Medical Corporation at 3 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 8 inclusion and 15 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: stopped early, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Oct 2023). 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 Success (time frame: during procedure). 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 NCT04375085.

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 25 Oct 2023.