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

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.