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

NCT ID: NCT02086006

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2017-04-30

Brief 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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DESolve scaffold

DESolve Novolimus Eluting Bioresorbable Coronary Scaffold. test arm, intervention

Group Type: OTHER

DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

Intervention Type: DEVICE

Interventions

DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Elixir Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Ormiston, MD

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital and Mercy Angiography Unit

Stefan Verheye, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ZNA Middelheim

Locations

AZ Middelheim Hospital

Antwerp, , Belgium

Auckland City Hospital

Auckland, , New Zealand

Mercy Angiography Unit

Auckland, , New Zealand

Countries

Belgium; New Zealand

Other Identifiers

ELX-CL-1002

Identifier Type: -

Identifier Source: org_study_id