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Coronary Artery DiseaseNCT03634020

DynamX Sirolimus Study Sirolimus Eluting Coronary Bioadaptor System

A study testing DynamX Sirolimus-eluting Coronary Bioadaptor System in people with Coronary Artery Disease, run by Elixir Medical Corporation at 7 sites in New Zealand.

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

To confirm the safety and performance of the DynamX Sirolimus-eluting Coronary Bioadaptor System (SECBS) in de novo native coronary artery lesions using clinical and imaging endpoints. Clinical follow-up will be conducted in all patients at 30 days, 6 and 12 months. Imaging follow-up will be conducted at 6 months. 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 Sirolimus-eluting Coronary Bioadaptor System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
7 sitesNew Zealand
Study dates
10 Dec 2018to 8 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

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

  • Patient must be at least 18 years of age
  • Patient is able to understand the risks, benefits and treatment alternatives of receiving the DynamX Sirolimus Eluting CBS and provide written informed consent, as approved by the NZ Ethics Committee, prior to any clinical study-related procedure
  • Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia)
  • Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
  • Women of childbearing potential with a negative pregnancy test within 7 days and women who are not pregnant or nursing
  • Patient must agree to undergo all clinical study required follow up visits, angiograms, and imaging testing
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  • Patient must agree not to participate in any other clinical research study for a period of one year following the index procedure Angiographic inclusion criteria- Target Lesion/Vessel
  • Target lesion(s) must be located in a native coronary artery with a vessel diameter of ≥ 2.5 and ≤3.5 mm assessed visually or by online QCA
  • Target lesion(s) must measure ≤ 24 mm in length
  • Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 90% with a TIMI flow of ≥ 2. When two target lesions are treated, they must be located in separate major epicardial vessels
  • The lesion(s) must be successfully pre-dilated (less than 35% DS) prior to enrollment
  • The target lesion length is 24 mm and able to be covered by a single DynamX Sirolimus Bioadaptor with 2 mm of healthy vessel on either side of planned implantation site
  • Treatment of a single, non-target lesion located in a separate major epicardial vessel

Who cannot join

  • Patient has a diagnosis of ST elevation myocardial infarction (STEMI) within 72 hours preceding the index procedure, and CK and CK-MB have not returned within normal limits at the time of procedure
  • Patient requires the use of rotational atherectomy during the index procedure
  • Patient has current unstable ventricular arrhythmias
  • Patient has a known left ventricular ejection fraction (LVEF) < 30%
  • Patient has received a heart transplant or any other organ transplant or is on a waiting list for an organ transplant
  • Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
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  • Patient is receiving immunosuppression therapy, other than steroids or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
  • Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, Sirolimus, CoCr alloys, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated
  • Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors.
  • Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented liver disease.
  • Patient has severe renal dysfunction (CKD IV or V, eGFR <30) or is on dialysis.
  • Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months
  • Patient has had a significant GI or urinary bleed within the past six months
  • Patient has a condition that precludes safe 6 French sheath insertion; or other medical conditions or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or associated with a limited life expectancy (i.e., less than one year)
  • Patient is already participating in another clinical study which has not reached the primary endpoint (long-term follow-up is not an exclusion) Angiographic Exclusion Criteria Target Lesion/Vessel
  • 1. Target/Vessel / Target lesion(s) meets any of the following criteria:
  • Aorto-ostial location
  • Left main location
  • Located within 5 mm of the origin of the LAD or LCX
  • Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
  • Lesion involving a bifurcation with a side branch >2mm in diameter
  • Previous placement of a stent within 10 mm of the target lesion
  • Total or sub-total occlusion (TIMI flow ≤1)
  • The proximal target vessel or target lesion is severely calcified by visual assessment, or the lesion prevents full pre-dilatation balloon expansion
  • Previous intervention restenosis 2. The target vessel contains visible thrombus 3. Another clinically-significant lesion (>50%) is located in the same major epicardial vessel as the target lesion 5. Target vessel was previously treated with any type of PCI < 6 months prior to index procedure 6. Non-Target vessel was previously treated with any type of PCI < 30 days prior to the index procedure

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

New Zealand7 sites

  • North Shore Hospital

    Auckland, 0622

  • Auckland City Hospital

    Auckland, 1023

  • Middlemore Hospital

    Auckland

  • Christchurch Hospital

    Christchurch

  • Dunedin Hospital

    Dunedin

  • Waikato Hospital

    Hamilton

  • Wellington Hospital

    Wellington, 6023

Other trials in New Zealand

About this study

Official title: Evaluation of a Thin Strut Metallic Coronary Device: the Elixir DynamXTM Sirolimus Eluting Coronary Bioadaptor System

To confirm the safety and performance of the DynamX Sirolimus-eluting Coronary Bioadaptor System (SECBS) in de novo native coronary artery lesions using clinical and imaging endpoints. Clinical follow-up will be conducted in all patients at 30 days, 6 and 12 months. Imaging follow-up will be conducted at 6 months.

Read the detailed description

The DynamX Sirolimus Study is a prospective, consecutive enrollment, single-arm study designed to enroll up to 30 patients requiring treatment of up to two de novo lesions ≤ 24 mm in length in vessels ≥ 2.5 mm and ≤ 3.5 mm in diameter.

One or two designated target lesions, located in separate epicardial vessels (RCA, LCX or LAD), and meeting the inclusion/exclusion criteria may be treated with the DynamX SECBS. Alternatively, one target lesion may be treated with the DynamX SECBS after successful, uncomplicated treatment of a non-target lesion, located in a separate epicardial vessel, with any commercially-available DES. Acceptable example: non-target RCA lesion and LAD target lesion. Not acceptable example: LAD non-target lesion and 1st diagonal target lesion.

The primary safety endpoint is Target Lesion Failure at 6 months. TLF is a composite endpoint defined as cardiac death, target vessel MI, and clinically-indicated target lesion revascularization The primary efficacy endpoint is late lumen loss at 6 months, assessed by angiography Additional secondary safety and effectiveness endpoints will be evaluated at 30 days, 6 and 12 months Using visual assessment, the target lesion must measure ≥ 2.5 mm and ≤ 3.5 mm in diameter and ≤ 24 mm in length able to be covered by a single DynamX Sirolimus Bioadaptor including 2 mm of healthy vessel on either side of the planned treatment area.

The patient will be eligible for stent (also called bioadaptor) implantation only after satisfactory lesion pre-dilatation defined as: ≥ TIMI 2 flow, and no dissection greater than Grade B (NHLBI) able to be covered with a single DynamX SECBS

Being tested
DynamX Sirolimus-eluting Coronary Bioadaptor System
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 Sirolimus-eluting Coronary Bioadaptor SystemDevice

    de novo native coronary artery lesions

Study groups in NCT03634020
Study groupRoleWhat they receive
DynamX Sirolimus-eluting Coronary Bioadaptor SystemExperimental2.5 - 3.5mm 14mm, 18mm and 28mm
Receives: Device: DynamX Sirolimus-eluting Coronary Bioadaptor System

What is being measured

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

  1. Target Lesion (s) Failure

    composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR

    Measured: 6 months

Secondary outcomes (22)

  1. Target Lesion (s) Failure

    composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR

    Measured: 1 month

  2. Target Lesion (s) Failure

    composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR

    Measured: 12 month

  3. cardiac death

    death from a cardiac cause

    Measured: 1 month

  4. Cardiac Death

    death from a cardiac cause

    Measured: 6 months

  5. Cardiac Death

    death from a cardiac cause

    Measured: 12 months

  6. Non-Cardiac Death

    death from a non-cardiac cause

    Measured: 1 month

  7. Non-Cardiac Death

    death from a non-cardiac cause

    Measured: 6 months

  8. Non-Cardiac Death

    death from a non-cardiac cause

    Measured: 12 months

  9. myocardial infarction

    all

    Measured: 1 month

  10. myocardial infarction

    all

    Measured: 6 months

  11. myocardial infarction

    all

    Measured: 12 months

  12. myocardial infarction

    related to the target vessel

    Measured: 1 month

  13. myocardial infarction

    related to the target vessel

    Measured: 6 months

  14. Target Lesion Revascularization

    Clinically indicated repeat intervention within the target lesion

    Measured: 1 month

  15. Target Lesion Revascularization

    Clinically indicated repeat intervention within the target lesion

    Measured: 6 months

  16. Target Lesion Revascularization

    Clinically indicated repeat intervention within the target lesion

    Measured: 12 months

  17. Target Vessel Revascularization

    Clinically indicated repeat intervention within the target vessel

    Measured: 1 month

  18. Target Vessel Revascularization

    Clinically indicated repeat intervention within the target vessel

    Measured: 6 months

  19. Target Vessel Revascularization

    Clinically indicated repeat intervention within the target vessel

    Measured: 12 months

  20. Device Thrombosis

    definite and probable as classified by an Academic Research Consortium

    Measured: 1 month

  21. Device Thrombosis

    definite and probable as classified by an Academic Research Consortium

    Measured: 6 months

  22. Device Thrombosis

    definite and probable as classified by an Academic Research Consortium

    Measured: 12 months

Timeline

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

  1. First posted16 Aug 2018
  2. Study start10 Dec 2018
  3. Primary completion8 Mar 2021
  4. Study completion8 Mar 2021

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
prospective, consecutive enrollment, single-arm study
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03634020
Sponsor's protocol ID
ELX-CL-1801
Status last verified
Apr 2021
First submitted
1 Aug 2018
Last updated
26 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DynamX Sirolimus-eluting Coronary Bioadaptor System in people with Coronary Artery Disease, run by Elixir Medical Corporation at 7 sites in New Zealand.

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 13 inclusion and 26 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 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in New Zealand. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Target Lesion (s) Failure (time frame: 6 months). 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 NCT03634020.

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 26 Apr 2021; AzTrials last refreshed its copy on 31 Oct 2026.

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