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Coronary Artery DiseaseNCT02086006

Elixir Medical Clinical Evaluation of the DESolve Myolimus Eluting Bioresorbable Coronary Stent System - DESolve I Trial

A study testing DESolve Novolimus Eluting Bioresorbable Coronary Scaffold in people with Coronary Artery Disease, run by Elixir Medical Corporation at 3 sites in 2 countries.

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

This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with single de novo, Type A lesions < 10 mm in length and located in a native coronary artery with a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline QCA and IVUS. 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?
DESolve Novolimus Eluting Bioresorbable Coronary Scaffold
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
3 sitesin 2 countries
Study dates
Feb 2011to Apr 2017
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 years and older
  • 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 verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DESolve Myolimus Eluting BCSS and he/she or his/her legally authorized representative provides written informed consent, as approved by the appropriate Ethics Committee of the respective clinical site, 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 electrocardiogram (ECG) changes consistent with ischemia)
  • Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
  • Patient must agree to undergo all clinical study required follow-up visits, angiograms, IVUS, OCT and MSCT
  • Patient must agree not to participate in any other clinical study for a period of two years following the index procedure

Who cannot join

  • Patients has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure
  • The patient is currently experiencing clinical symptoms consistent with AMI
  • Patient has current unstable arrhythmias Patient has undergone previous percutaneous interventions for lesions in either a non-target vessel or target vessel Patient has undergone previous percutaneous interventions for lesions in either a non-target vessel or target vessel
  • 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 any organ transplant
  • Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure
Show all 19Show fewer
  • Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
  • Patient is receiving or scheduled to receive chronic anticoagulation therapy (e.g., heparin, coumadin)
  • Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, both clopidogrel and ticlopidine, Myolimus, 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
  • Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease.
  • Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient 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 extensive peripheral vascular disease that precludes safe 7 French sheath insertion
  • Patient has other medical illness (e.g., cancer or congestive heart failure) 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 is associated with a limited life expectancy (i.e., less than one year)
  • Patient is already participating in another clinical study
  • Women of childbearing potential who have not undergone surgical sterilization or is not post-menopausal (defined as amenorrheic for at least one year)

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

New Zealand2 sites

  • Auckland City Hospital

    Auckland, 1023

  • Mercy Angiography Unit

    Auckland, 1023

Other trials in New Zealand

Belgium1 site

  • AZ Middelheim Hospital

    Antwerp, 2020

Other trials in Belgium

About this study

Official title: A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATION OF THE DESolveTM MYOLIMUS ELUTING BIORESORBABLE CORONARY STENT SYSTEM IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS

This prospective, consecutive enrolment, single-arm study will enroll up to 15 patients with single de novo, Type A lesions < 10 mm in length and located in a native coronary artery with a reference vessel diameter of 2.75 mm - 3.0 mm as measured by both offline QCA and IVUS. All patients will receive a 3.0 x 14mm DESolve Stent loaded with approximately 40 mcg of Myolimus.

  • Angiographic and intravascular ultrasound (IVUS) will be completed for all patients at baseline and at 6 months.
  • Optical Coherence Tomography (OCT) will will be completed for all patients at baseline and at 6 months.
  • Multi-slice computed tomography (MSCT) will be conducted on all patients enrolled at 12 and 24 months.
Being tested
DESolve Novolimus Eluting Bioresorbable Coronary Scaffold
Keywords
Coronary artery disease
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.

  • DESolve Novolimus Eluting Bioresorbable Coronary ScaffoldDevice

Study groups in NCT02086006
Study groupRoleWhat they receive
DESolve scaffoldOtherDESolve Novolimus Eluting Bioresorbable Coronary Scaffold. test arm, intervention
Receives: Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

What is being measured

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

  1. Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)

    Measured: 1 month

  2. Clinically-Indicated Target Lesion Failure (CI-TLF)

    Measured: 1 month

  3. Clinically-Indicated Target Vessel Failure (CI-TVF)

    Measured: 1 month

  4. Clinically-Indicated Target Vessel Revascularization (CI-TVR)

    Measured: 1 month

  5. Stent thrombosis

    Measured: 1 month

  6. Acute success - Procedure success

    Acute Success is classified according to the following definitions:

    Procedure success - Attainment of final result, < 50% residual stenosis of the target site, using the DESolve Myolimus Eluting BCSS device without the occurrence of in-hospital any Major Adverse Cardiac Endpoints.

    Measured: 7 days

  7. Acute success - Device success

    Acute Success is classified according to the following definitions:

    Device success - Attainment of final result, < 50% residual stenosis of the target site, using the study stent without the need for other non-study stents.

    Measured: 7 days

  8. Stent thrombosis

    Measured: 6 months

  9. Stent thrombosis

    Measured: 12 months

  10. Stent thrombosis

    Measured: 2 years

  11. Stent thrombosis

    Measured: 3 years

  12. Stent thrombosis

    Measured: 4 years

  13. Stent thrombosis

    Measured: 5 years

  14. Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)

    Measured: 6 months

  15. Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)

    Measured: 12 months

  16. Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)

    Measured: 2 years

  17. Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)

    Measured: 3 years

  18. Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)

    Measured: 4 years

  19. Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)

    Measured: 5 years

  20. Clinically-Indicated Target Lesion Failure (CI-TLF)

    Measured: 6 months

  21. Clinically-Indicated Target Lesion Failure (CI-TLF)

    Measured: 12 months

  22. Clinically-Indicated Target Lesion Failure (CI-TLF)

    Measured: 2 years

  23. Clinically-Indicated Target Lesion Failure (CI-TLF)

    Measured: 3 years

  24. Clinically-Indicated Target Lesion Failure (CI-TLF)

    Measured: 4 years

  25. Clinically-Indicated Target Lesion Failure (CI-TLF)

    Measured: 5 years

  26. Clinically-Indicated Target Vessel Failure (CI-TVF)

    Measured: 6 months

  27. Clinically-Indicated Target Vessel Failure (CI-TVF)

    Measured: 12 months

  28. Clinically-Indicated Target Vessel Failure (CI-TVF)

    Measured: 2 years

  29. Clinically-Indicated Target Vessel Failure (CI-TVF)

    Measured: 3 years

  30. Clinically-Indicated Target Vessel Failure (CI-TVF)

    Measured: 4 years

  31. Clinically-Indicated Target Vessel Failure (CI-TVF)

    Measured: 5 years

  32. Clinically-Indicated Target Vessel Revascularization (CI-TVR)

    Measured: 6 months

  33. Clinically-Indicated Target Vessel Revascularization (CI-TVR)

    Measured: 12 months

  34. Clinically-Indicated Target Vessel Revascularization (CI-TVR)

    Measured: 2 years

  35. Clinically-Indicated Target Vessel Revascularization (CI-TVR)

    Measured: 3 years

  36. Clinically-Indicated Target Vessel Revascularization (CI-TVR)

    Measured: 4 years

  37. Clinically-Indicated Target Vessel Revascularization (CI-TVR)

    Measured: 5 years

Timeline

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

  1. First posted13 Mar 2014 (estimated)
  2. Study startFeb 2011
  3. Primary completionOct 2016
  4. Study completionApr 2017

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
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02086006
Sponsor's protocol ID
ELX-CL-1002
Status last verified
Sep 2023
First submitted
10 Mar 2014
Last updated
7 Sep 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing DESolve Novolimus Eluting Bioresorbable Coronary Scaffold in people with Coronary Artery Disease, run by Elixir Medical Corporation at 3 sites in 2 countries.

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 19 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 7 Sep 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 New Zealand, Belgium. 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?

Clinically-Indicated Major Adverse Cardiac Event (CI-MACE) (time frame: 1 month). The study lists 37 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 NCT02086006.

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 7 Sep 2023.

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