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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) -

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01093300
Recruitment Status : Unknown
Verified March 2010 by Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 25, 2010
Last Update Posted : March 25, 2010
Information provided by:
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
In-stent Restenosis Lesion Device: Paclitaxel-eluting balloon catheter Device: Everolimus-eluting stent Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Late luminal loss in the inflation/in-stent segment [ Time Frame: 9 months ]
  2. Target lesion/vessel revascularization, myocardial infarction [ Time Frame: 1, 2 years ]
  3. Periprocedural myocardial infarction [ Time Frame: 3 days ]
  4. % diameter stenosis in the analysis segment & in the inflation/in-stent segment [ Time Frame: 9 months ]
  5. Neointimal volume, % neointimal volume, % volume obstruction [ Time Frame: 9 months ]
    The above parameters will be assessed by IVUS

  6. Time interval from device insertion to initiation of deployment [ Time Frame: 0 days ]
  7. Stent thrombosis [ Time Frame: 1, 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01093300

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Contact: Kyung-Woo Park, MD, PhD 82-2-2072-2044
Contact: Hyo-Soo Kim, MD, PhD 82-2-2072-2226

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Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-744
Principal Investigator: Hyo-Soo Kim, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Seoul National University Hospital IRB, Seoul National University Hospital Identifier: NCT01093300     History of Changes
Other Study ID Numbers: HOST-ISR trial
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: March 25, 2010
Last Verified: March 2010
Additional relevant MeSH terms:
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Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents