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CompletedNCT02086006Updated Sep 7, 2023

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

An interventional study of DESolve Novolimus Eluting Bioresorbable Coronary Scaffold in Coronary Artery Disease, sponsored by Elixir Medical Corporation. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-07.

Sponsored by Elixir Medical Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary artery disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 16 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Elixir Medical Corporation is the lead sponsor of 18 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Other
    DESolve scaffold

    DESolve Novolimus Eluting Bioresorbable Coronary Scaffold. test arm, intervention

    Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

Interventions

  • DeviceDESolve Novolimus Eluting Bioresorbable Coronary Scaffold
06

What researchers measure

Primary outcomes

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

    Time frame: 1 month

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

    Time frame: 1 month

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

    Time frame: 1 month

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

    Time frame: 1 month

  5. Stent thrombosis

    Time frame: 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.

    Time frame: 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.

    Time frame: 7 days

  8. Stent thrombosis

    Time frame: 6 months

  9. Stent thrombosis

    Time frame: 12 months

  10. Stent thrombosis

    Time frame: 2 years

  11. Stent thrombosis

    Time frame: 3 years

  12. Stent thrombosis

    Time frame: 4 years

  13. Stent thrombosis

    Time frame: 5 years

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

    Time frame: 6 months

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

    Time frame: 12 months

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

    Time frame: 2 years

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

    Time frame: 3 years

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

    Time frame: 4 years

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

    Time frame: 5 years

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

    Time frame: 6 months

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

    Time frame: 12 months

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

    Time frame: 2 years

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

    Time frame: 3 years

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

    Time frame: 4 years

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

    Time frame: 5 years

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

    Time frame: 6 months

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

    Time frame: 12 months

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

    Time frame: 2 years

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

    Time frame: 3 years

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

    Time frame: 4 years

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

    Time frame: 5 years

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

    Time frame: 6 months

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

    Time frame: 12 months

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

    Time frame: 2 years

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

    Time frame: 3 years

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

    Time frame: 4 years

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

    Time frame: 5 years

07

Study locations

3 sites
  • AZ Middelheim Hospital
    Antwerp, 2020, Belgium
  • Auckland City Hospital
    Auckland, 1023, New Zealand
  • Mercy Angiography Unit
    Auckland, 1023, New Zealand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02086006
Lead sponsor
Elixir Medical Corporation
Responsible party
Sponsor
First posted
Mar 13, 2014
Start date
Feb 2011
Primary completion
Oct 2016
Completion
Apr 2017
Last update
Sep 7, 2023

Study contacts

John Ormiston, MD
principal investigator · Auckland City Hospital and Mercy Angiography Unit
Stefan Verheye, MD, PhD
principal investigator · ZNA Middelheim

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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