In Stent RestenosisPhase 4FOCUSNCT00485004
Focal In-stent Restenosis After Drug-Eluting Stent
A Phase 4 study testing Cutting balloon and Sirolimus-eluting stent in people with In Stent Restenosis, run by Seung-Jung Park at 15 sites in South Korea.
Trial summary
To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In Stent Restenosis
- What is being tested?
- Cutting balloon and Sirolimus-eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 15 sitesSouth Korea
- Study dates
- Mar 2007to Mar 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be at least 18 years of age.
- Restenosis after drug-eluting stents (>50% by visual estimate)
- Lesion length < 10 mm (focal ISR)
- Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- Heparin
- Aspirin
- Both Clopidogrel and TIclopidine
- Sirolimus eluting stent
- Stainless steel and/or
Show all 19Show fewer
- Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
- Systemic (intravenous) Sirolimus use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Patients with EF<30%.
- Acute MI patients within symptom onset < 12 hours needing primary angioplasty
- Creatinine level 3.0mg/dL or dependence on dialysis.
- Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
- Patients with left main stem stenosis and left main in-stent restenosis created by DES(>50% by visual estimate)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Korea15 sites
Soonchunhyang University Bucheon Hospital
Bucheon-si
Choeng Ju St.Mary's Hospital
Choeng Ju
Kangwon National University Hospital
Chuncheon
Chungnam National University Hospital
Daejeon
Asan Medical Center
Gangneung
DongGuk University Gyongju Hospital
Gyongju
Chonbuk National University Hospital
Jeonju
Kwangju Christian Hospital
Kwangju
Inje University Pusan Paik Hospital
Pusan
Hallym University Sacred Heart Hospital,
Pyeongchon
Asan Medical Center
Seoul, 138-736
Hangang Sacred Heart Hospital
Seoul
Kyungsang University Hospital
Seoul
Seoul Veterans Hospital
Seoul
Ulsan University Hospital
Ulsan
About this study
Official title: FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent
To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty
Read the detailed description
Following angiography, patients with focal DES restenosis (lesion length ≤ 10mm) with diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for PCI without any exclusion criteria will be randomized 1:1 to: a) Cypher stent vs. b) Cutting balloon angioplasty. All patients will be followed for 1 year. Angiographic follow-up at 9-months is mandatory.
- Conditions
- In Stent Restenosis
- Being tested
- Cutting balloon, Sirolimus-eluting stent
- Keywords
- Coronary artery disease, Stent, Angioplasty
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutting balloonDevice
Cutting balloon
Sirolimus-eluting stentDevice
Sirolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Cutting balloon | Experimental | Cutting balloon Receives: Device: Cutting balloon; Device: Sirolimus-eluting stent |
| Sirolimus-eluting stent | Active comparator | Sirolimus-eluting stent Receives: Device: Cutting balloon; Device: Sirolimus-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary In-segment Restenosis
Measured: At 9 months angiographic follow-up
Secondary outcomes (4)
Composite end-point of death, myocardial infarction, or target vessel revascularization
Measured: At 9-month after index procedure
Stent thrombosis
Measured: In-hospital, 30 days, 9 months, and 1year
Late luminal loss
Measured: at 8 month angiographic follow-up
Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion
Measured: during the hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Stent RestenosisStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, CardioVascular Research Foundation, Korea
- Investigators
- Seung-Jung Park, MD, PhD, Principal investigator, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485004
- Sponsor's protocol ID
- 20070041
- Acronym
- FOCUS
- Status last verified
- Aug 2012
- First submitted
- 11 Jun 2007
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent
- ClinicalTrials.gov ID
- NCT00485004
- Acronym / sponsor ID
- FOCUS / 20070041
- Conditions
- In Stent Restenosis
- Keywords
- Coronary artery disease, Stent, Angioplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Mar 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 12 Jun 2007 (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.
To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty
Detailed description
Following angiography, patients with focal DES restenosis (lesion length ≤ 10mm) with diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for PCI without any exclusion criteria will be randomized 1:1 to: a) Cypher stent vs. b) Cutting balloon angioplasty. All patients will be followed for 1 year. Angiographic follow-up at 9-months is mandatory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cutting balloon | Experimental | Device: Cutting balloon, Device: Sirolimus-eluting stentCutting balloon |
| Sirolimus-eluting stent | Active comparator | Device: Cutting balloon, Device: Sirolimus-eluting stentSirolimus-eluting stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient must be at least 18 years of age.
- Restenosis after drug-eluting stents (>50% by visual estimate)
- Lesion length < 10 mm (focal ISR)
- Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (19 listed)
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- Systemic (intravenous) Sirolimus use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- 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 |
|---|---|---|
| Cutting balloonCutting balloon | Device | Cutting balloon, Sirolimus-eluting stent |
| Sirolimus-eluting stentSirolimus-eluting stent | Device | Cutting balloon, Sirolimus-eluting stent |
Primary outcome
Binary In-segment Restenosis
Time frame: At 9 months angiographic follow-up
4 secondary outcomes
Composite end-point of death, myocardial infarction, or target vessel revascularization
Time frame: At 9-month after index procedure
Stent thrombosis
Time frame: In-hospital, 30 days, 9 months, and 1year
Late luminal loss
Time frame: at 8 month angiographic follow-up
Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion
Time frame: during the hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
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Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
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A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
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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.
Seung-Jung Park, MD, PhD principal investigator
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cutting balloon and Sirolimus-eluting stent in people with In Stent Restenosis, run by Seung-Jung Park at 15 sites 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 5 inclusion and 19 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: finished, as of the sponsor's last update on 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binary In-segment Restenosis (time frame: At 9 months angiographic follow-up). 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 8 Aug 2012.