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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DESolve scaffold; DESolve Novolimus Eluting Bioresorbable Coronary Scaffold. test arm, intervention	Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent thrombosis		6 months
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		1 month
Clinically-Indicated Target Lesion Failure (CI-TLF)		1 month
Clinically-Indicated Target Vessel Failure (CI-TVF)		1 month
Clinically-Indicated Target Vessel Revascularization (CI-TVR)		1 month
Stent thrombosis		1 month
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.	7 days
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.	7 days
Stent thrombosis		12 months
Stent thrombosis		2 years
Stent thrombosis		3 years
Stent thrombosis		4 years
Stent thrombosis		5 years
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		6 months
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		12 months
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		2 years
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		3 years
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		4 years
Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		5 years
Clinically-Indicated Target Lesion Failure (CI-TLF)		6 months
Clinically-Indicated Target Lesion Failure (CI-TLF)		12 months
Clinically-Indicated Target Lesion Failure (CI-TLF)		2 years
Clinically-Indicated Target Lesion Failure (CI-TLF)		3 years
Clinically-Indicated Target Lesion Failure (CI-TLF)		4 years
Clinically-Indicated Target Lesion Failure (CI-TLF)		5 years
Clinically-Indicated Target Vessel Failure (CI-TVF)		6 months
Clinically-Indicated Target Vessel Failure (CI-TVF)		12 months
Clinically-Indicated Target Vessel Failure (CI-TVF)		2 years
Clinically-Indicated Target Vessel Failure (CI-TVF)		3 years
Clinically-Indicated Target Vessel Failure (CI-TVF)		4 years
Clinically-Indicated Target Vessel Failure (CI-TVF)		5 years
Clinically-Indicated Target Vessel Revascularization (CI-TVR)		6 months
Clinically-Indicated Target Vessel Revascularization (CI-TVR)		12 months
Clinically-Indicated Target Vessel Revascularization (CI-TVR)		2 years
Clinically-Indicated Target Vessel Revascularization (CI-TVR)		3 years
Clinically-Indicated Target Vessel Revascularization (CI-TVR)		4 years
Clinically-Indicated Target Vessel Revascularization (CI-TVR)		5 years

Collaborators and Investigators

• Sponsor: Elixir Medical Corporation
• Investigators: Principal Investigator: John Ormiston, MD, Auckland City Hospital and Mercy Angiography Unit; Principal Investigator: Stefan Verheye, MD, PhD, ZNA Middelheim

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 11, 2014
• First Posted (Estimated): March 13, 2014

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Coronary artery disease
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: ELX-CL-1002