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ACTIVE NOT RECRUITING
NCT05364697
NA

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

Sponsor: Medinol Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2022-08-30

Completion Date

2029-12

Last Updated

2024-11-21

Healthy Volunteers

No

Interventions

DEVICE

IoNIR Ridaforolimus-Eluting Coronary Stent System

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.

Locations (4)

InCor

São Paulo, Brazil

Meir Medical Center

Kfar Saba, Israel

Rabin Medical Center

Petah Tikva, Israel

Sourasky Medical Center

Tel Aviv, Israel