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) -

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: In-stent Restenosis Lesion

Treatments: Device: Paclitaxel-eluting balloon catheter; Device: Everolimus-eluting stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01093300

HOST-ISR trial

Details and patient eligibility

About

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.

Enrollment: 264 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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264 participants in 2 patient groups

Paclitaxel-eluting balloon catheter

Experimental group

Description:

Paclitaxel-eluting balloon catheter use for treatment of ISR lesion

Treatment:

Device: Paclitaxel-eluting balloon catheter

Everolimus-eluting stent

Active Comparator group

Description:

Everolimus-eluting stent use for treatment of ISR lesion

Treatment:

Device: Everolimus-eluting stent