Comparison of the Efficacy of Paclitaxel-releasing Balloo... | NCT01093300

Studies
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) -

NCT01093300

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Apr 20, 2023Actual

Enrollment

264Estimated

Phase

Phase 4

Conditions

In-stent Restenosis Lesion

Interventions

Paclitaxel-eluting balloon catheter
Everolimus-eluting stent

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 24, 2010

First Submission Date that Met QC Criteria

Mar 24, 2010

First Posted Date

Mar 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2023

Last Update Posted Date

Apr 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

264Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Paclitaxel-eluting balloon catheter	Device		Paclitaxel-eluting balloon catheter
Everolimus-eluting stent

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kyung-Woo Park, MD, PhD	Contact	82-2-2072-2044		kwparkmd@snu.ac.kr
Hyo-Soo Kim, MD, PhD	Contact	82-2-2072-2226		hyosoo@snu.ac.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea