Clinical trial NCT02086006: Elixir Medical Clinical Evaluation of the DESolve Myolimus Eluting Bioresorbable Coronary Stent System - DESolve I 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Lead sponsor: Elixir Medical Corporation
Sponsor class: INDUSTRY
First posted: 2014-03-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
timeFrame: 1 month
measure: Clinically-Indicated Target Lesion Failure (CI-TLF)
timeFrame: 1 month
measure: Clinically-Indicated Target Vessel Failure (CI-TVF)
timeFrame: 1 month
measure: Clinically-Indicated Target Vessel Revascularization (CI-TVR)
timeFrame: 1 month
measure: Stent thrombosis
timeFrame: 1 month
measure: Acute success - Procedure success
timeFrame: 7 days
measure: Acute success - Device success
timeFrame: 7 days
measure: Stent thrombosis
timeFrame: 6 months
measure: Stent thrombosis
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 2 years
measure: Stent thrombosis
timeFrame: 3 years
measure: Stent thrombosis
timeFrame: 4 years
measure: Stent thrombosis
timeFrame: 5 years
measure: Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
timeFrame: 6 months
measure: Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
timeFrame: 12 months
measure: Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
timeFrame: 2 years
measure: Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
timeFrame: 3 years
measure: Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
timeFrame: 4 years
measure: Clinically-Indicated Major Adverse Cardiac Event (CI-MACE)
timeFrame: 5 years
measure: Clinically-Indicated Target Lesion Failure (CI-TLF)
timeFrame: 6 months
measure: Clinically-Indicated Target Lesion Failure (CI-TLF)
timeFrame: 12 months
measure: Clinically-Indicated Target Lesion Failure (CI-TLF)
timeFrame: 2 years
measure: Clinically-Indicated Target Lesion Failure (CI-TLF)
timeFrame: 3 years
measure: Clinically-Indicated Target Lesion Failure (CI-TLF)
timeFrame: 4 years
measure: Clinically-Indicated Target Lesion Failure (CI-TLF)
timeFrame: 5 years
measure: Clinically-Indicated Target Vessel Failure (CI-TVF)
timeFrame: 6 months
measure: Clinically-Indicated Target Vessel Failure (CI-TVF)
timeFrame: 12 months
measure: Clinically-Indicated Target Vessel Failure (CI-TVF)
timeFrame: 2 years
measure: Clinically-Indicated Target Vessel Failure (CI-TVF)
timeFrame: 3 years
measure: Clinically-Indicated Target Vessel Failure (CI-TVF)
timeFrame: 4 years
measure: Clinically-Indicated Target Vessel Failure (CI-TVF)
timeFrame: 5 years
measure: Clinically-Indicated Target Vessel Revascularization (CI-TVR)
timeFrame: 6 months
measure: Clinically-Indicated Target Vessel Revascularization (CI-TVR)
timeFrame: 12 months
measure: Clinically-Indicated Target Vessel Revascularization (CI-TVR)
timeFrame: 2 years
measure: Clinically-Indicated Target Vessel Revascularization (CI-TVR)
timeFrame: 3 years
measure: Clinically-Indicated Target Vessel Revascularization (CI-TVR)
timeFrame: 4 years
measure: Clinically-Indicated Target Vessel Revascularization (CI-TVR)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: AZ Middelheim Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Auckland
country: New Zealand
facility: Mercy Angiography Unit
Study officials:
affiliation: Auckland City Hospital and Mercy Angiography Unit
name: John Ormiston, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ZNA Middelheim
name: Stefan Verheye, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: