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To demonstrate acceptable short term safety rates of the Drug-eluting Coronary Spur Stent System as a primary treatment for coronary in-stent restenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting Coronary Spur StEnt System | Experimental | All subjects enrolled will receive the Drug-eluting Coronary Spur Stent System. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-eluting Coronary Spur Stent System | Device | All subjects enrolled will be treated with the Drug-eluting Coronary Spur Stent System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment of the target lesion with the Drug-Eluting Coronary Spur Stent System without occurrence of in-hospital Major Adverse Cardiac Events (MACE). | MACE is defined as All-cause death, Myocardial Infarction (MI), any clinically-driven target lesion revascularization (TLR). | From time of enrollment procedure through time of post-procedure discharge |
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Pre-Procedure Inclusion Criteria:
Angiographic Inclusion Criteria:
Pre-procedure Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auckland City Hospital Te Toka Tumai | Auckland | Grafton | 1142 | New Zealand | ||
| Wellington Hospital | Capital, Coast and Hutt Valley |
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| Wellington |
| Wellington Region |
| 6023 |
| New Zealand |