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

NCT02086006 | Completed DMC

• 1 other identifier: ELX-CL-1002
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 3

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

Keywords

Coronary artery disease

Outcome Measures

Primary Outcomes (37)

• 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

  6 months

• 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

Study Arms (1)

DESolve scaffold

OTHER

DESolve Novolimus Eluting Bioresorbable Coronary Scaffold. test arm, intervention

Device: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold

Interventions

DESolve Novolimus Eluting Bioresorbable Coronary Scaffold DEVICE

DESolve scaffold

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elixir Medical Corporation: lead

Study Sites (3)

AZ Middelheim Hospital

Antwerp, 2020, Belgium

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Mercy Angiography Unit

Auckland, 1023, New Zealand

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• John Ormiston, MD

  Auckland City Hospital and Mercy Angiography Unit

  PRINCIPAL INVESTIGATOR

• Stefan Verheye, MD, PhD

  ZNA Middelheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 13, 2014
• Study Start: February 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: April 1, 2017
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

BE (1); NZ (2)