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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

• Registration Number: NCT02086006
• Lead Sponsor: Elixir Medical Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Primary Completion: 2016-10
• Study Completion: 2017-04
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-05
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DESolve scaffold	DESolve Novolimus Eluting Bioresorbable Coronary Scaffold	DESolve Novolimus Eluting Bioresorbable Coronary Scaffold. test arm, intervention

Primary Outcome Measures

Name	Time	Method
Stent thrombosis	5 years
Acute success - Procedure success	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.
Acute success - Device success	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.
Clinically-Indicated Target Vessel Revascularization (CI-TVR)	5 years
Clinically-Indicated Target Lesion Failure (CI-TLF)	5 years
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)	5 years
Clinically-Indicated Target Vessel Failure (CI-TVF)	5 years

Trial Locations

Locations (3)

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Mercy Angiography Unit; 🇳🇿 Auckland, New Zealand

AZ Middelheim Hospital; 🇧🇪 Antwerp, Belgium