NCT01093300

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
Last Updated

April 20, 2023

Status Verified

March 1, 2013

First QC Date

March 24, 2010

Last Update Submit

April 19, 2023

Conditions

In-stent Restenosis Lesion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

    9 months

  • +2 more secondary outcomes

Study Arms (2)

Paclitaxel-eluting balloon catheter

EXPERIMENTAL

Paclitaxel-eluting balloon catheter use for treatment of ISR lesion

Device: Paclitaxel-eluting balloon catheter

Everolimus-eluting stent

ACTIVE COMPARATOR

Everolimus-eluting stent use for treatment of ISR lesion

Device: Everolimus-eluting stent

Interventions

Paclitaxel-eluting balloon catheterDEVICE
Paclitaxel-eluting balloon catheter
Everolimus-eluting stentDEVICE
Everolimus-eluting stent

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Central Study Contacts

Kyung-Woo Park, MD, PhD

CONTACT

82-2-2072-2044kwparkmd@snu.ac.kr

Hyo-Soo Kim, MD, PhD

CONTACT

82-2-2072-2226hyosoo@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 25, 2010

Last Updated

April 20, 2023

Record last verified: 2013-03

Locations

KR(1)