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) -

Study Overview
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Brief Summary
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In-stent restenosis (ISR) lesions are considered one of the toughest lesions that interventional cardiologists encounter in the drug eluting stent (DES) era. The current consensus in treating ISR is implantation of another DES into the restenosed segment. However the recent results of paclitaxel-releasing balloon catheter (PRBC) in ISR lesions have been very encouraging. The aim of HOST-ISR trial is to investigate the efficacy and safety of PRBC compared with everolimus-eluting stent (EES) in preventing neointimal growth in ISR lesions. HOST-ISR trial is a multicenter, open-label, prospective, randomized trial to test whether PRBC is non-inferior to EES in preventing neointimal growth in ISR lesions. It plans to enroll a total of 264 patients with ISR, randomizing the cohort 1:1 to either PRBC or EES. The primary endpoint will be in-segment late luminal loss at 9 months angiographical follow-up.

Conditions
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In-stent Restenosis Lesion

Intervention / Treatment
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* Device: Paclitaxel-eluting balloon catheter
* Device: Everolimus-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 18y 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: Hypersensitivity to aspirin, clopidogrel, heparin, sirolimus, paclitaxel or radiocontrast media 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel-eluting balloon catheter<br>Paclitaxel-eluting balloon catheter use for treatment of ISR lesion | Device: Paclitaxel-eluting balloon catheter<br> <br> |
| Active Comparator: Everolimus-eluting stent<br>Everolimus-eluting stent use for treatment of ISR lesion | Device: Everolimus-eluting stent<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late luminal loss in the analysis segment | Analysis segment is defined as +/- 5mm of the previous stented/inflated segment of the vessel | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late luminal loss in the inflation/in-stent segment |  | 9 months | 
| Target lesion/vessel revascularization, myocardial infarction |  | 1, 2 years | 
| Periprocedural myocardial infarction |  | 3 days | 
| % diameter stenosis in the analysis segment & in the inflation/in-stent segment |  | 9 months | 
| Neointimal volume, % neointimal volume, % volume obstruction | The above parameters will be assessed by IVUS | 9 months | 
| Time interval from device insertion to initiation of deployment |  | 0 days | 
| Stent thrombosis |  | 1, 2 years |