Prospective, Multi-center, Single-arm, Open-label Clinical Trial, to Further Assess the Safety and Efficacy of Long (38 mm) Ridaforolimus Eluting Stent - EluNIR

Medinol Ltd.1 site in 1 country50 target enrollmentNovember 14, 2018

ConditionsCoronary Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Stenosis
Sponsor: Medinol Ltd.
Enrollment: 50
Locations: 1
Primary Endpoint: Primary Endpoint: Device Success
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up will be performed at 30 days. Follow-up by phone will be performed at 6 months, and 1 year after the procedure. Study Objective is to further assess the safety and efficacy of long (38 mm) Ridaforolimus Eluting Stent - EluNIR.

Registry

clinicaltrials.gov

Start Date

November 14, 2018

End Date

April 30, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medinol Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•General Inclusion Criteria:
•Age ≥ 18 years.
•Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI, or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be \>24 hours prior to enrollment and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked.
•An attempt (whether successful or not) was made to implant a 38 mm EluNIR stent (Stent was advanced beyond the guiding catheter).
•Non-target vessel PCI are allowed prior to the screening for eligibility depending on the time interval and conditions as follows:
•During Baseline Procedure:
•PCI of non-target vessels performed during the baseline procedure itself immediately prior to screening for eligibility, if successful and uncomplicated defined as: \<50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding.
•Less than 24 hours prior to Baseline Procedure:
•Not allowed (see exclusion criteria #2). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to the baseline procedure if successful and uncomplicated as defined above.
•ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must have been drawn at least 6 and 12 hours after the non-target vessel PCI.

Exclusion Criteria

•General Exclusion Criteria:
•STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin) have not peaked.
•PCI within the 24 hours preceding the baseline procedure.
•Non-target lesion PCI in the target vessel within 12 months of the baseline procedure.
•History of stent thrombosis.
•Cardiogenic shock (defined as persistent hypotension (systolic blood pressure \<90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP.
•Subject is intubated.
•Known LVEF \<30%.
•Relative or absolute contraindication to DAPT for 6 months in non-ACS patients and 12 months in ACS patients (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment).
•eGFR \<30 mL/min

Outcomes

Primary Outcomes

Primary Endpoint: Device Success

Time Frame: 30 day

Device success is defined as achievement of a final in-stent residual diameter stenosis of \<50% (by QCA), using the assigned device only and without a device malfunction.

Primary Endpoint: No 30 Day MACE (Major Adverse Cardiac Events)

Time Frame: 30 Day

No 30 day MACE: MACE (Major Adverse Cardiac Events) is defined as the composite of cardiac death, any MI, or ischemia-driven TLR.