IonMAN Trial- First in Human Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System

NCT05364697 | Active Not Recruiting DMC

• 1 other identifier: IoNIR-001
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 4

Brief Summary

This is a prospective, multi-center, single-arm, open-label, First in Human clinical trial to provide preliminary evidence for the safety and efficacy of the novel IoNIR stent system.

Conditions

Coronary Stenosis; Coronary Disease; Non-ST Elevated Myocardial Infarction; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 1In-stent Late Loss (LL)

  In-stent Late Loss (LL) at 1 year (cohort B) assessed by quantitative coronary angiography (QCA) (Minimal Lumen Diameter (MLD) post-procedure - MLD follow-up)

  1 year

• Target Lesion Failure

  Target Lesion Failure (composite of cardiovascular death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year

  1 year

Secondary Outcomes (36)

• Major adverse cardiac events

  30 days, 6 months, 1, 2, 3, 4, 5 years

• All-cause mortality

  30 days, 6 months, 1, 2, 3, 4, 5 years

• Cardiovascular death

  30 days, 6 months, 1, 2, 3, 4, 5 years

• Myocardial infarction

  30 days, 6 months, 1, 2, 3, 4, 5 years

• Target vessel related MI

  30 days, 6 months, 1, 2, 3, 4, 5 years

Study Arms (1)

IoNIR Ridaforolimus-Eluting Coronary Stent

EXPERIMENTAL

IoNIR Ridaforolimus-Eluting Coronary Stent System

Device: IoNIR Ridaforolimus-Eluting Coronary Stent System

Interventions

IoNIR Ridaforolimus-Eluting Coronary Stent System DEVICE

The IoNIR Ridaforolimus-Eluting Coronary Stent System is a sterile single-use device/drug combination product, comprised of a cobalt chromium (CoCr) alloy-based stent coated with a bioresorbable polymer mesh which is embedded with drug, mounted on a Rapid Exchange (RX) delivery system.

Also known as: IoNIR

IoNIR Ridaforolimus-Eluting Coronary Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Patient with an indication for PCI including NSTEMI (biomarkers have peaked or are falling), 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, Pd/Pa≤0.91or iFR, RFR, DFR, DPR≤0.89 must be present).
• Non-target vessel PCIs are allowed if performed \>30 days prior to index procedure.
• Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.
• Staged procedures are allowed as long as the IoNIR stent is implanted in the last procedure and at least 30 days have elapsed between the previous procedure and the IoNIR PCI.
• One de novo target lesion ONLY may be treated (more than one lesion separated by less than 5 mm are considered one lesion).
• Target lesion must be in a major native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.0 mm and lesion length of up to 28 mm, and appropriate size IoNIR stent is available

You may not qualify if:

• ST Segment Elevation MI within past 30 days.
• NSTEMI with biomarkers that have not peaked.
• Significant valvular disease or planned valvular intervention.
• PCI within the 30 days preceding the baseline procedure.
• PCI in the target vessel within 12 months of the baseline procedure.
• Planned staged procedures (coronary or valvular), where the study stent is implanted in the first stage.
• Brachytherapy in conjunction with the baseline procedure.
• Known 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).
• Subject has an indication such as atrial fibrillation for oral anticoagulation/prolonged heparinization (i.e., use of coumadin/DOAC (NOAC) or prolonged enoxaparin/heparin therapy is not allowed).
• eGFR \<60 mL/min.
• Hemoglobin \<10 g/dL.

Sponsors & Collaborators

• Medinol Ltd.: lead

Study Sites (4)

InCor

São Paulo, Brazil

Location

Meir Medical Center

Kfar Saba, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Coronary Stenosis; Coronary Disease; Non-ST Elevated Myocardial Infarction; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: August 30, 2022
• Primary Completion: September 30, 2024
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

BR (1); IL (3)