Optimal Treatment for Coronary Drug Eluting Stent In-stent Restenosis

Coronary Stent Restenosis Clinical Trial

— OPEN-ISR  

Official title:

OPtimal trEatment for coroNary Drug Eluting Stent In-Stent Restenosis: Paclitaxel Versus Sirolimus Coated Balloons Versus Everolimus Eluting Stents - The OPEN ISR Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04862052
• Other study ID #: OPEN ISR - 001
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: January 1, 2025

Study information

• Verified date: April 2024
• Source: Semmelweis University Heart and Vascular Center
• Contact: István F Édes, MD PhD
• Phone: +3614586810
• Email: edes789[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this open label, randomized study is to compare the safety and efficacy of three different methods to handle coronary drug eluting stent (DES) in-stent restenosis (ISR).

These are the:

• Magic Touch - sirolimus coated balloon

• Emperor - paclitaxel and dextran coated balloon

• Xience - chromium-cobalt everolimus eluting stent

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients admitted for intervention of drug eluting stent restenosis

• Restenosis suitable for all three treatment arms as per 'instructions for use' of the devices

• Optional enrollment in the optical coherence tomography sub-study (10-20% of patients)

Exclusion Criteria:

• Patients undergoing coronary angiography after sudden cardiac death

• Pregnant or nursing

Related Conditions & MeSH terms

• Coronary Stent Restenosis

Intervention

Procedure:
• Intravascular management of prior implanted coronary drug eluting stent restenosis
Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management.

Locations

Country	Name	City	State
Hungary	Semmelweis University Heart and Vascular Center	Budapest
Hungary	University of Szeged, Department of Invasive Cardiology	Szeged	Csongád-Csanád

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University Heart and Vascular Center

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

Kulyassa P, Nemeth BT, Ehrenberger R, Ruzsa Z, Szuk T, Fehervari P, Engh MA, Becker D, Merkely B, Edes IF. The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial. Front Cardiovasc Med. 2022 May 27;9:881266. doi: 10.3389/fcvm.2022.881266. eCollection 2022. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of new onset target vessel myocardial infarction	New onset myocardial infarction that affects the target vessel treated with either study device	6 months
Primary	Occurrence of target vessel revascularization of failure	The need for further revascularization affecting the target vessel treated with either study device, or the failure of the vessel treated by either study device.	6 months
Primary	Occurrence of target lesion revascularization	The need for further revascularization of the target lesion after treatment with either study device.	6 months
Secondary	Percentage late lumen loss	Late lumen loss measured via qualitative coronary angiography in treated segment(s)	6 months
Secondary	Percentage intraluminal gain after treatment	Intraluminal gain after assigned treatment measured via optical coherence tomography	index procedure
Secondary	Square millimetre intraluminal gain after treatment	Intraluminal gain after assigned treatment measured via optical coherence tomography	index procedure
Secondary	Percentage intraluminal gain after treatment	Intraluminal gain after assigned treatment measured via optical coherence tomography	6 months
Secondary	Square millimeter intraluminal gain after treatment	Intraluminal gain after assigned treatment measured via optical coherence tomography	6 months
Secondary	Endothelium coverage in micrometers	Mean endothelium thickness of stent struts in micrometres measured via optical coherence tomography	6 months
Secondary	Late lumen loss in square millimetres	Late lumen loss in square millimetres measured via optical coherence tomography	6 months

External Links

•   Link to design and feasibility manuscript