In-stent Restenosis LesionPhase 4NCT01093300
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) -
A Phase 4 study testing Paclitaxel-eluting balloon catheter and Everolimus-eluting stent in people with In-stent Restenosis Lesion, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- In-stent Restenosis Lesion
- What is being tested?
- Paclitaxel-eluting balloon catheter and Everolimus-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, 110-744
Hyo-Soo Kim, MD, PhD
About this study
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
- In-stent Restenosis Lesion
- Being tested
- Paclitaxel-eluting balloon catheter, Everolimus-eluting stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-eluting balloon catheterDevice
Everolimus-eluting stentDevice
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-eluting balloon catheter | Experimental | Paclitaxel-eluting balloon catheter use for treatment of ISR lesion Receives: Device: Paclitaxel-eluting balloon catheter |
| Everolimus-eluting stent | Active comparator | Everolimus-eluting stent use for treatment of ISR lesion Receives: Device: Everolimus-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late luminal loss in the analysis segment
Analysis segment is defined as +/- 5mm of the previous stented/inflated segment of the vessel
Measured: 9 months
Secondary outcomes (7)
Late luminal loss in the inflation/in-stent segment
Measured: 9 months
Target lesion/vessel revascularization, myocardial infarction
Measured: 1, 2 years
Periprocedural myocardial infarction
Measured: 3 days
% diameter stenosis in the analysis segment & in the inflation/in-stent segment
Measured: 9 months
Neointimal volume, % neointimal volume, % volume obstruction
The above parameters will be assessed by IVUS
Measured: 9 months
Time interval from device insertion to initiation of deployment
Measured: 0 days
Stent thrombosis
Measured: 1, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-stent Restenosis LesionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093300
- Sponsor's protocol ID
- HOST-ISR trial
- Status last verified
- Mar 2013
- First submitted
- 24 Mar 2010
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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) -
- ClinicalTrials.gov ID
- NCT01093300
- Acronym / sponsor ID
- HOST-ISR trial
- Conditions
- In-stent Restenosis Lesion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- First posted
- 25 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-eluting balloon catheter | Experimental | Device: Paclitaxel-eluting balloon catheterPaclitaxel-eluting balloon catheter use for treatment of ISR lesion |
| Everolimus-eluting stent | Active comparator | Device: Everolimus-eluting stentEverolimus-eluting stent use for treatment of ISR lesion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel-eluting balloon catheter | Device | Paclitaxel-eluting balloon catheter |
| Everolimus-eluting stent | Device | Everolimus-eluting stent |
Primary outcome
Late luminal loss in the analysis segment
Time frame: 9 months
Analysis segment is defined as +/- 5mm of the previous stented/inflated segment of the vessel
7 secondary outcomes
Late luminal loss in the inflation/in-stent segment
Time frame: 9 months
Target lesion/vessel revascularization, myocardial infarction
Time frame: 1, 2 years
Periprocedural myocardial infarction
Time frame: 3 days
% diameter stenosis in the analysis segment & in the inflation/in-stent segment
Time frame: 9 months
Neointimal volume, % neointimal volume, % volume obstruction
Time frame: 9 months
Time interval from device insertion to initiation of deployment
Time frame: 0 days
Stent thrombosis
Time frame: 1, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paclitaxel-eluting balloon catheter and Everolimus-eluting stent in people with In-stent Restenosis Lesion, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kyung-Woo Park, MD, PhD (82-2-2072-2044, kwparkmd@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late luminal loss in the analysis segment (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.