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) -

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.

Study Overview

• Status: Unknown
• Conditions: In-stent Restenosis Lesion
• Intervention / Treatment: Device: Paclitaxel-eluting balloon catheter; Device: Everolimus-eluting stent

• Study Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kyung-Woo Park, MD, PhD; Phone Number: 82-2-2072-2044; Email: kwparkmd@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (Estimate): March 25, 2010

Study Record Updates

• Last Update Posted (Actual): April 20, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Everolimus
• Other Study ID Numbers: HOST-ISR trial