Comparison of the Efficacy of Paclitaxel-releasing Balloon Catheter System Versus the Everolimus-Eluting Stent System for Treatment of In-Stent Restenosis Lesions - Harmonizing Optimal Strategy for Treatment of In-Stent Restenosis Lesions (The HOST-ISR Trial) -
NCT ID: NCT01093300
Last Updated: 2023-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
264 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Paclitaxel-eluting balloon catheter
Paclitaxel-eluting balloon catheter use for treatment of ISR lesion
Paclitaxel-eluting balloon catheter
Everolimus-eluting stent
Everolimus-eluting stent use for treatment of ISR lesion
Everolimus-eluting stent
Interventions
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Paclitaxel-eluting balloon catheter
Everolimus-eluting stent
Eligibility Criteria
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Inclusion Criteria
* Significant ISR lesion (\>50% by visual estimate) of previously stented de novo coronary artery
* Evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the electrocardiogram (ECG) consistent with ischemia) or ISR with diameter stenosis \> 70%
* Written, informed consent
* Target lesion(s) located in a native coronary artery within a previously stented lesion with previous stent diameter of ≥ 2.5 mm and ≤ 4.00 mm
* Target lesion(s) amenable for percutaneous coronary intervention
Exclusion Criteria
* Systemic sirolimus use within 12 months
* Female of childbearing potential
* History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia)
* Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months
* Non-cardiac co-morbid conditions present with life expectancy \<1 year or that may result in protocol non-compliance
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
* ISR of left main coronary artery
* Restenosis of two stented bifurcation lesion
18 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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HOST-ISR trial
Identifier Type: -
Identifier Source: org_study_id
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