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

Coronary Artery Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086006
• Other study ID #: ELX-CL-1002
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: April 2017

Study information

• Verified date: September 2023
• Source: Elixir Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

Locations

Country	Name	City	State
Belgium	AZ Middelheim Hospital	Antwerp
New Zealand	Auckland City Hospital	Auckland
New Zealand	Mercy Angiography Unit	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Elixir Medical Corporation

Countries where clinical trial is conducted

Belgium,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		1 month
Primary	Clinically-Indicated Target Lesion Failure (CI-TLF)		1 month
Primary	Clinically-Indicated Target Vessel Failure (CI-TVF)		1 month
Primary	Clinically-Indicated Target Vessel Revascularization (CI-TVR)		1 month
Primary	Stent thrombosis		1 month
Primary	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
Primary	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
Primary	Stent thrombosis		6 months
Primary	Stent thrombosis		12 months
Primary	Stent thrombosis		2 years
Primary	Stent thrombosis		3 years
Primary	Stent thrombosis		4 years
Primary	Stent thrombosis		5 years
Primary	Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		6 months
Primary	Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		12 months
Primary	Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		2 years
Primary	Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		3 years
Primary	Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		4 years
Primary	Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)		5 years
Primary	Clinically-Indicated Target Lesion Failure (CI-TLF)		6 months
Primary	Clinically-Indicated Target Lesion Failure (CI-TLF)		12 months
Primary	Clinically-Indicated Target Lesion Failure (CI-TLF)		2 years
Primary	Clinically-Indicated Target Lesion Failure (CI-TLF)		3 years
Primary	Clinically-Indicated Target Lesion Failure (CI-TLF)		4 years
Primary	Clinically-Indicated Target Lesion Failure (CI-TLF)		5 years
Primary	Clinically-Indicated Target Vessel Failure (CI-TVF)		6 months
Primary	Clinically-Indicated Target Vessel Failure (CI-TVF)		12 months
Primary	Clinically-Indicated Target Vessel Failure (CI-TVF)		2 years
Primary	Clinically-Indicated Target Vessel Failure (CI-TVF)		3 years
Primary	Clinically-Indicated Target Vessel Failure (CI-TVF)		4 years
Primary	Clinically-Indicated Target Vessel Failure (CI-TVF)		5 years
Primary	Clinically-Indicated Target Vessel Revascularization (CI-TVR)		6 months
Primary	Clinically-Indicated Target Vessel Revascularization (CI-TVR)		12 months
Primary	Clinically-Indicated Target Vessel Revascularization (CI-TVR)		2 years
Primary	Clinically-Indicated Target Vessel Revascularization (CI-TVR)		3 years
Primary	Clinically-Indicated Target Vessel Revascularization (CI-TVR)		4 years
Primary	Clinically-Indicated Target Vessel Revascularization (CI-TVR)		5 years