In-stent Arterial RestenosisPhase 4RestenosisNCT01365572
New Generation Drug Eluting Stent for In-stent Restenosis of Drug Eluting Stent( RESTENT-ISR Trial )
A Phase 4 study testing Xiene V stent, Endeavor Resolute stent in people with In-stent Arterial Restenosis, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the feasibility, safety, and effectiveness of EndeavorTM ResoluteTM and Xience VTM stent implantation in patients with restenosis following drug-eluting stent (DES) implantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- In-stent Arterial Restenosis
- What is being tested?
- Xiene V stent, Endeavor Resolute stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Mar 2012
- 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
- In-stent restenosis (over 50% by quantitative angiographic analysis) following all types of DES; only insegment restenotic lesions without ISR are not included
- Evidence of myocardial ischemia due to restenosis (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the ECG with or without ischemia) or over 70% by quantitative angiographic analysis
- Repeat revascularization, needed with another stent (single stent implanted lesion, lesion length no more than 28mm )
- IVUS available lesions
- Non-emergent conditions
- Patients confirmed about study enrollment and 9 month followup angiogram and IVUS
Who cannot join
- Lesion \& Procedural exclusion criteria
- IVUS unavailable lesion
- Restenotic lesions following PCI of de novo lesion like as below;
- left main lesions
- BMS restenotic lesion
- vein graft lesion
Show all 21Show fewer
- Restenotic lesions following 2.25mm DES implantation
- Prior history of repeat DES implantation for DES restenosis (only conventional or cutting ballooning treatment for DES restenosis is included in this study)
- Simultaneous implantation of different types of DES on restenotic or another de novo lesions (Only same DES implantation is allowed on the restenotic or another de novo lesions)
- Patients with little possibility of performing follow-up angiogram and IVUS
- General exclusion criteria
- Contraindication to anti-platelet agents \& Bleeding history within prior 3 months
- Prior history or current presentation of DES thrombosis
- Age over 80 years
- Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Zotarolimus, Everolimus
- Severe hepatic dysfunction (3 times normal reference values)
- Serum creatinine level over 2.0 mg/dL or end-stage renal diseases on dialysis
- LVEF less than 30%
- Pregnant women or women with potential childbearing
- An elective surgical procedure is planned that would necessitate interruption of clopidogrel during the first 9 months
- Life expectancy 1 year
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yousei Universty Healthcare System
Seoul
Yangsoo Jang, MD, PhD, +82-2228-8321
About this study
Official title: Prospective, Single-blinded, Randomized Comparison of the Clinical and Angiographic Results With Intravascular Analysis of EverolimuS-Eluting Versus ZoTarolimus-Eluting steNTs for In-Stent Restenosis(ISR) Lesions: Volumetric Analysis With Intravascular Ultrasound(IVUS) : Phase IV Multicenter Trial ( RESTENT-ISR Trial )
The purpose of this study is to evaluate the feasibility, safety, and effectiveness of EndeavorTM ResoluteTM and Xience VTM stent implantation in patients with restenosis following drug-eluting stent (DES) implantation. The investigators will evaluate clinical, angiographic and intravascular ultrasound (IVUS) assessment of 9-month efficacy of EndeavorTM ResoluteTM or Xience VTM implantation in DES restenosis and assess the vascular changes of re-treatment with DES for DES restenosis using follow-up IVUS analysis. In addition, the investigators will evaluate the effectiveness of retreatment with EndeavorTM ResoluteTM or Xience VTM stent implantation in patients with restenosis after DES
- Conditions
- In-stent Arterial Restenosis
- Being tested
- Xiene V stent, Endeavor Resolute stent
- Keywords
- Drug-eluting stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiene V stent, Endeavor Resolute stentDevice
for each lesion, randomized either Xience V stent or Endeavor Resolute stent
| Study group | Role | What they receive |
|---|---|---|
| Xience V, drug-eluting stent | Active comparator | randomized implantation for DES restenotic lesion Receives: Device: Xiene V stent, Endeavor Resolute stent |
| Endeavor Resolute, drug-eluting stent | Active comparator | randomized implantation for DES restenotic lesion Receives: Device: Xiene V stent, Endeavor Resolute stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent neointimal volume index
Measured: 9 months on IVUS
Secondary outcomes (2)
Major adverse cardiovascular events
Safety end-point; to evaluate the procedural success and the incidence of 12-month death, MI, target-vessel failure (TVF), or stent thrombosis
Measured: 12 months
Efficacy end-point
Efficacy end-point; to evaluate the 9-month binary angiographic restenosis (≥50 percent in-stent diameter stenosis) and late loss, vascular remodeling during follow-up
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startJan 2010
- Primary completionSep 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-stent Arterial 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic Medical Center, KangWon National University Hospital, Kyungpook National University Hospital, Kunyang University Medical center, Kyunghee University Medical Center, Kyemyeong Univerisity Medical Center, Korea University Guro Hospital, Kwandong Univerisity Medical Center, Kwangjoo Veteran Hospital, Eulji University, Dankook University, Daegoo Catholic Medical College, Dong-A University, Sejong General Hospital, Busan University Medical Center, Seoul National University Medical Center, Sunkyungwan Univeristy Medical Center, Suncheonyang University Medical Center, Yonsei University, Yongnam University Medical Center, Wonkwang University, Inje Univerisity Medical Center, Chonnam National University, Chung-Ang University, Hallym University Medical Center, Chungnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365572
- Sponsor's protocol ID
- AN09049-004
- Acronym
- Restenosis
- Status last verified
- Mar 2011
- First submitted
- 31 May 2011
- Last updated
- 3 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-blinded, Randomized Comparison of the Clinical and Angiographic Results With Intravascular Analysis of EverolimuS-Eluting Versus ZoTarolimus-Eluting steNTs for In-Stent Restenosis(ISR) Lesions: Volumetric Analysis With Intravascular Ultrasound(IVUS) : Phase IV Multicenter Trial ( RESTENT-ISR Trial )
- ClinicalTrials.gov ID
- NCT01365572
- Acronym / sponsor ID
- Restenosis / AN09049-004
- Conditions
- In-stent Arterial Restenosis
- Keywords
- Drug-eluting stent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- Catholic Medical Center, KangWon National University Hospital, Kyungpook National University Hospital, Kunyang University Medical center, Kyunghee University Medical Center, Kyemyeong Univerisity Medical Center, Korea University Guro Hospital, Kwandong Univerisity Medical Center, Kwangjoo Veteran Hospital, Eulji University, Dankook University, Daegoo Catholic Medical College, Dong-A University, Sejong General Hospital, Busan University Medical Center, Seoul National University Medical Center, Sunkyungwan Univeristy Medical Center, Suncheonyang University Medical Center, Yonsei University, Yongnam University Medical Center, Wonkwang University, Inje Univerisity Medical Center, Chonnam National University, Chung-Ang University, Hallym University Medical Center, Chungnam National University
- Study start
- Jan 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 3 Jun 2011 (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.
The purpose of this study is to evaluate the feasibility, safety, and effectiveness of EndeavorTM ResoluteTM and Xience VTM stent implantation in patients with restenosis following drug-eluting stent (DES) implantation. The investigators will evaluate clinical, angiographic and intravascular ultrasound (IVUS) assessment of 9-month efficacy of EndeavorTM ResoluteTM or Xience VTM implantation in DES restenosis and assess the vascular changes of re-treatment with DES for DES restenosis using follow-up IVUS analysis. In addition, the investigators will evaluate the effectiveness of retreatment with EndeavorTM ResoluteTM or Xience VTM stent implantation in patients with restenosis after DES
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xience V, drug-eluting stent | Active comparator | Device: Xiene V stent, Endeavor Resolute stentrandomized implantation for DES restenotic lesion |
| Endeavor Resolute, drug-eluting stent | Active comparator | Device: Xiene V stent, Endeavor Resolute stentrandomized implantation for DES restenotic 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)
- In-stent restenosis (over 50% by quantitative angiographic analysis) following all types of DES; only insegment restenotic lesions without ISR are not included
- Evidence of myocardial ischemia due to restenosis (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or a reversible changes in the ECG with or without ischemia) or over 70% by quantitative angiographic analysis
- Repeat revascularization, needed with another stent (single stent implanted lesion, lesion length no more than 28mm )
- IVUS available lesions
- Non-emergent conditions
Key exclusion criteria (21 listed)
- Lesion \& Procedural exclusion criteria
- IVUS unavailable lesion
- Restenotic lesions following PCI of de novo lesion like as below;
- Restenotic lesions following 2.25mm DES implantation
- Prior history of repeat DES implantation for DES restenosis (only conventional or cutting ballooning treatment for DES restenosis is included in this study)
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 |
|---|---|---|
| Xiene V stent, Endeavor Resolute stentfor each lesion, randomized either Xience V stent or Endeavor Resolute stent | Device | Endeavor Resolute, drug-eluting stent, Xience V, drug-eluting stent |
Primary outcome
In-stent neointimal volume index
Time frame: 9 months on IVUS
2 secondary outcomes
Major adverse cardiovascular events
Time frame: 12 months
Efficacy end-point
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2011.
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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 Xiene V stent, Endeavor Resolute stent in people with In-stent Arterial Restenosis, run by Korea University Anam 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 21 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 3 Jun 2011. 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 Korea University Anam Hospital Ahn, MD, PhD (+82-2-920-5445, drcello@kumc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent neointimal volume index (time frame: 9 months on IVUS). 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 3 Jun 2011.