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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06117150




Registration number
NCT06117150
Ethics application status
Date submitted
28/09/2023
Date registered
3/11/2023

Titles & IDs
Public title
Pilot Study of the Coronary Spur Stent for In-stent Restenosis (DEEPER CORONARY)
Scientific title
A Pilot Study of the Drug-eluting Coronary Spur StEnt as a Primary trEatment for In-stent Restenosis of the CORONARY Arteries (DEEPER CORONARY)
Secondary ID [1] 0 0
CP-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
In-stent Restenosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Drug-eluting Coronary Spur Stent System

Experimental: Drug-eluting Coronary Spur StEnt System - All subjects enrolled will receive the Drug-eluting Coronary Spur Stent System.


Treatment: Devices: Drug-eluting Coronary Spur Stent System
All subjects enrolled will be treated with the Drug-eluting Coronary Spur Stent System.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment of the target lesion with the Drug-Eluting Coronary Spur Stent System without occurrence of in-hospital Major Adverse Cardiac Events (MACE).
Timepoint [1] 0 0
From time of enrollment procedure through time of post-procedure discharge

Eligibility
Key inclusion criteria
Pre-Procedure

1. 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.
2. Life expectancy greater than 2 years in the investigator's opinion.
3. Subject is greater than 18 years of age.
4. Female subjects of childbearing potential have a negative pregnancy test = 7 days before the procedure.
5. Endovascular treatment is able to be conducted under non-emergent conditions.
6. 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.
7. Subject is eligible for dual antiplatelet therapy (DAPT) treatment with aspirin plus P2Y12 inhibitor.

Angiographic

1. Target vessel is of appropriate size and diameter to be treated with the Coronary Spur Stent.
2. Target lesion is within a previously placed Bare Metal Stent (BMS) or Drug-eluting Stent (DES) and does not extend further than 5mm beyond either the proximal or distal edge of the stent.
3. In-stent restenosis of >50% diameter by angiography.
4. Up to two (2) non-target lesions in non-target vessels may be treated, but successful percutaneous coronary intervention (PCI) of the non-target lesions must be completed before treatment of the target lesion. Successful treatment of a non-target lesion is defined as a residual stenosis of = 30% in 2 near-orthogonal projections with Thrombolysis in Myocardial Infarction (TIMI) 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI.
5. Successful pre-dilatation of the target lesion, defined as non-compromised flow or presence of thrombus.

Pre-procedure
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject unwilling or unlikely to comply with the one-year duration of the study as in the opinion of the investigator.
2. Subject is pregnant, breast-feeding, or is a woman of childbearing potential who is not using appropriate contraceptives.
3. Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
4. Stroke within 90 days of the index procedure.
5. Documented left ventricular ejection fraction (LVEF) <35% by echocardiography.
6. In-stent restenosis occurring in less than 90 days prior to the index procedure.

Impaired renal function (eGFR less than or equal to 25 mL/min) within 30 days of procedure or end stage renal disease on dialysis.

8. History of active peptic ulcer or gastrointestinal bleeding within prior 6 months or other inability to comply with recommended duration of DAPT.

9. Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which could not be substituted, drug balloon coatings and their excipients, including, but not limited to, paclitaxel, sirolimus, or zotarolimus, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.

10. The subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.

11. Known allergy to nitinol or nickel.

12. Any expected elective surgical procedure that would necessitate interruption of DAPT through the 12-month visit.

13. Planned use of atherectomy (rotational, orbital, or laser) device, cutting or scoring balloon.

14. Severe hepatic dysfunction (3 times normal reference values).

15. Planned treatment of additional lesions in target vessel or > two (2) non-target lesions within non-target vessels during index procedure.

16. Target lesion has undergone > two (2) prior stent implant procedures (including the initial index procedure, i.e., > two (2) layers of stent are present at any segment of target lesion).

Angiographic Exclusion Criteria

1. Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
2. Fractured or otherwise compromised stents in the target vessel or inflow vessel.
3. Target lesion and vessel tortuosity must accommodate the Drug-eluting Coronary Spur.
4. Severe Calcification of the target vessel.
5. Prior history of repeat drug-eluting stent implantation for DES restenosis.
6. Angiographic evidence of thrombus within target artery.
7. Type D dissections or greater incurred during predilitation or crossing (see Appendix II for definitions).
8. Tortuosity of proximal segment or location of In-stent Restenosis (ISR) or extremely angulated segments which prevents tracking of the Coronary Spur Stent to the target lesion.
9. Total occlusions > 3 months old and/or bridging collaterals.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ReFlow Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Isula
Address 0 0
Country 0 0
Phone 0 0
(949) 481-0399
Fax 0 0
Email 0 0
aisula@reflowmedical.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06117150