Skip to main content
OpenTrials
Completed

NCT Number: NCT02086006

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Middelheim Hospital, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

Device

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

    Time frame: 7 days

    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.

  7. Acute success - Device success

    Time frame: 7 days

    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.

  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

Sponsors and collaborators

Lead sponsor

Elixir Medical Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2016
Study completion
2017
First posted
Mar 13, 2014
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.