Active — Not RecruitingPhase 1

Pilot Study of the Coronary Spur Stent for In-stent Restenosis (DEEPER CORONARY)

New Zealand10 participantsStarted 2024-06-09

Plain-language summary

To demonstrate acceptable short term safety rates of the Drug-eluting Coronary Spur Stent System as a primary treatment for coronary in-stent restenosis.

Who can participate

SexALL

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Inclusion criteria

✓. Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a legal guardian or legally authorized representative (LAR) sign on their behalf.
✓. Life expectancy greater than 2 years in the investigator's opinion.
✓. Subject is greater than 18 years of age.
✓. Female subjects of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure.
✓. Endovascular treatment is able to be conducted under non-emergent conditions.
✓. Documented stable or unstable angina including non-ST-elevation MI, functional testing demonstrating ischemia, and/or clinical symptoms that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention.
✓. Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus P2Y12 inhibitor.
✓. Target vessel is of appropriate size and diameter to be treated with the Coronary Spur Stent.

Exclusion criteria

✕. Subject unwilling or unlikely to comply with the one-year duration of the study as in the opinion of the investigator.
✕. Subject is pregnant, breast-feeding, or is a woman of childbearing potential who is not using appropriate contraceptives.
✕. Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
✕. Stroke within 90 days of the index procedure.
✕. Documented left ventricular ejection fraction (LVEF) \<35% by echocardiography.
✕. In-stent restenosis occurring in less than 90 days prior to the index procedure.
✕. Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
✕. Fractured or otherwise compromised stents in the target vessel or inflow vessel.

What they're measuring

Treatment of the target lesion with the Drug-Eluting Coronary Spur Stent System without occurrence of in-hospital Major Adverse Cardiac Events (MACE).

Timeframe: From time of enrollment procedure through time of post-procedure discharge

Trial details

NCT IDNCT06117150

SponsorReFlow Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More In-stent Restenosis trials