Clinical trial NCT01093300: 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) -
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: In-stent Restenosis Lesion
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Late luminal loss in the analysis segment
timeFrame: 9 months
Secondary outcomes:
measure: Late luminal loss in the inflation/in-stent segment
timeFrame: 9 months
measure: Target lesion/vessel revascularization, myocardial infarction
timeFrame: 1, 2 years
measure: Periprocedural myocardial infarction
timeFrame: 3 days
measure: % diameter stenosis in the analysis segment & in the inflation/in-stent segment
timeFrame: 9 months
measure: Neointimal volume, % neointimal volume, % volume obstruction
timeFrame: 9 months
measure: Time interval from device insertion to initiation of deployment
timeFrame: 0 days
measure: Stent thrombosis
timeFrame: 1, 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: