DynamX Sirolimus Study Sirolimus Eluting Coronary Bioadaptor System

NCT03634020 | Completed FDA Device

• 1 other identifier: ELX-CL-1801
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 7

Brief Summary

To confirm the safety and performance of the DynamX Sirolimus-eluting Coronary Bioadaptor System (SECBS) in de novo native coronary artery lesions using clinical and imaging endpoints. Clinical follow-up will be conducted in all patients at 30 days, 6 and 12 months. Imaging follow-up will be conducted at 6 months.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Target Lesion (s) Failure

  composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR

  6 months

Secondary Outcomes (22)

• Target Lesion (s) Failure

  1 month

• Target Lesion (s) Failure

  12 month

• cardiac death

  1 month

• Cardiac Death

  6 months

• Cardiac Death

  12 months

Other Outcomes (2)

• Qualitative coronary angiography

  6 months

• Intravascular ultrasound imaging

  6 months

Study Arms (1)

DynamX Sirolimus-eluting Coronary Bioadaptor System

EXPERIMENTAL

2.5 - 3.5mm 14mm, 18mm and 28mm

Device: DynamX Sirolimus-eluting Coronary Bioadaptor System

Interventions

DynamX Sirolimus-eluting Coronary Bioadaptor System DEVICE

de novo native coronary artery lesions

DynamX Sirolimus-eluting Coronary Bioadaptor System

Eligibility Criteria

• Age: 18 Years - 80 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 understand the risks, benefits and treatment alternatives of receiving the DynamX Sirolimus Eluting CBS and provide written informed consent, as approved by the NZ Ethics Committee, 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 or electrocardiogram (ECG) changes consistent with ischemia)
• Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
• Women of childbearing potential with a negative pregnancy test within 7 days and women who are not pregnant or nursing
• Patient must agree to undergo all clinical study required follow up visits, angiograms, and imaging testing
• Target lesion(s) must be located in a native coronary artery with a vessel diameter of ≥ 2.5 and ≤3.5 mm assessed visually or by online QCA
• Target lesion(s) must measure ≤ 24 mm in length
• Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 90% with a TIMI flow of ≥ 2. When two target lesions are treated, they must be located in separate major epicardial vessels
• The lesion(s) must be successfully pre-dilated (less than 35% DS) prior to enrollment
• The target lesion length is 24 mm and able to be covered by a single DynamX Sirolimus Bioadaptor with 2 mm of healthy vessel on either side of planned implantation site
• Treatment of a single, non-target lesion located in a separate major epicardial vessel

You may not qualify if:

• Patient has a diagnosis of ST elevation myocardial infarction (STEMI) within 72 hours preceding the index procedure, and CK and CK-MB have not returned within normal limits at the time of procedure
• Patient requires the use of rotational atherectomy during the index procedure
• Patient has current unstable ventricular arrhythmias
• 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 an 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, other than steroids or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.)
• Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, Sirolimus, CoCr alloys, 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 or other P2Y12 inhibitors.
• Patient has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented liver disease.
• Patient has severe renal dysfunction (CKD IV or V, eGFR \<30) or is 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 a condition that precludes safe 6 French sheath insertion; or other medical conditions 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 associated with a limited life expectancy (i.e., less than one year)

Sponsors & Collaborators

• Elixir Medical Corporation: lead

Study Sites (7)

North Shore Hospital

Auckland, 0622, New Zealand

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Middlemore Hospital

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Dunedin Hospital

Dunedin, New Zealand

Location

Waikato Hospital

Hamilton, New Zealand

Location

Wellington Hospital

Wellington, 6023, 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 Design

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

Model Details: prospective, consecutive enrollment, single-arm study

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 16, 2018
• Study Start: December 10, 2018
• Primary Completion: March 8, 2021
• Study Completion: March 8, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (7)