Coronary AngiographyDEFER-DESNCT00592228
Proper Fractional Flow Reserve Criteria for Intermediate Lesions in the Era of Drug-eluting Stent
A study testing Cypher, Taxus or Endeavor in people with Coronary Angiography and Drug-eluting Stents, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Angiographic evaluation for intermediate lesions is not always accurate. Fractional flow reserve-guided deferral strategy for these lesions showed the same event rate as routine intervention strategy. However, proper FFR criterion for these lesions in the era of drug-eluting stent is not known. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography, Drug-eluting Stents, Fractional Flow Reserve, Myocardial
- What is being tested?
- Cypher, Taxus or Endeavor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2007to Jan 2009
- Phase
- Interventional
- 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
- Elective PCI
- Angiographically intermediate stenosis (50-75% by visual estimation) in native major coronary arteries, proximal and mid (branch, distal lesion: exclusion)
- Reference diameter > 2.5mm, lesion length < 60mm (cover by 2 stents)
- No documented evidence of ischemia by noninvasive tests
Who cannot join
- Acute ST elevation MI
- Left main disease
- Chronic renal failure (cr >2 mg/dL)
- Expected survival < 2yrs
- > 1degree AV block
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Deferral of Angioplasty According to Fractional Flow Reserve vs. Routine Drug-eluting Stent Implantation in Intermediate Coronary Stenosis
Angiographic evaluation for intermediate lesions is not always accurate. Fractional flow reserve-guided deferral strategy for these lesions showed the same event rate as routine intervention strategy. However, proper FFR criterion for these lesions in the era of drug-eluting stent is not known. This study sought to evaluate the clinical outcomes of intermediate lesions according to FFR and compare those of FFR-guided intervention with routine drug-eluting stent implantation strategy.
- Being tested
- Cypher, Taxus or Endeavor
- Keywords
- intermediate lesion, drug-eluting stent, fractional flow reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cypher, Taxus or EndeavorDevice
percutaneous drug-eluting stent implantation,
- FFR group: if FFR<0.75
- Routine DES group
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Fractional flow guided drug-eluting stent implantation arm Receives: Device: Cypher, Taxus or Endeavor |
| 2 | Other | Routine drug-eluting stent implantation Receives: Device: Cypher, Taxus or Endeavor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical event: Cardiac death, myocardial infarction, target lesion revascularization
Measured: 9 months
Secondary outcomes (1)
IVUS
IVUS minimum lumen area
Measured: at the time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2009 (estimated)
- Study completionJan 2009 (estimated)
Why it stopped: due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary AngiographyStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Bon-Kwon Koo, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592228
- Sponsor's protocol ID
- H-0706-026-210
- Acronym
- DEFER-DES
- Status last verified
- Dec 2010
- First submitted
- 17 Dec 2007
- Last updated
- 21 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park SH, Jeon KH, Lee JM, Nam CW, Doh JH, Lee BK, Rha SW, Yoo KD, Jung KT, Cho YS, Lee HY, Youn TJ, Chung WY, Koo BK. Long-Term Clinical Outcomes of Fractional Flow Reserve-Guided Versus Routine Drug-Eluting Stent Implantation in Patients With Intermediate Coronary Stenosis: Five-Year Clinical Outcomes of DEFER-DES Trial. Circ Cardiovasc Interv. 2015 Dec;8(12):e002442. doi: 10.1161/CIRCINTERVENTIONS.115.002442.
PubMed 26643736
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deferral of Angioplasty According to Fractional Flow Reserve vs. Routine Drug-eluting Stent Implantation in Intermediate Coronary Stenosis
- ClinicalTrials.gov ID
- NCT00592228
- Acronym / sponsor ID
- DEFER-DES / H-0706-026-210
- Keywords
- intermediate lesion, drug-eluting stent, fractional flow reserve
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to slow enrollment
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 11 Jan 2008 (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.
Angiographic evaluation for intermediate lesions is not always accurate. Fractional flow reserve-guided deferral strategy for these lesions showed the same event rate as routine intervention strategy. However, proper FFR criterion for these lesions in the era of drug-eluting stent is not known. This study sought to evaluate the clinical outcomes of intermediate lesions according to FFR and compare those of FFR-guided intervention with routine drug-eluting stent implantation strategy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Cypher, Taxus or EndeavorFractional flow guided drug-eluting stent implantation arm |
| 2 | Other | Device: Cypher, Taxus or EndeavorRoutine drug-eluting stent implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective PCI
- Angiographically intermediate stenosis (50-75% by visual estimation) in native major coronary arteries, proximal and mid (branch, distal lesion: exclusion)
- Reference diameter > 2.5mm, lesion length < 60mm (cover by 2 stents)
- No documented evidence of ischemia by noninvasive tests
Key exclusion criteria (5 listed)
- Acute ST elevation MI
- Left main disease
- Chronic renal failure (cr >2 mg/dL)
- Expected survival < 2yrs
- > 1degree AV block
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 |
|---|---|---|
| Cypher, Taxus or Endeavorpercutaneous drug-eluting stent implantation, 1. FFR group: if FFR<0.75 2. Routine DES group | Device | 1, 2 |
Primary outcome
Clinical event: Cardiac death, myocardial infarction, target lesion revascularization
Time frame: 9 months
1 secondary outcome
IVUS
Time frame: at the time of procedure
Results and safety
The study was stopped early (reason given: due to slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2010.
- Derived from this study: PubMed 26643736Park SH, Jeon KH, Lee JM, Nam CW, Doh JH, Lee BK, Rha SW, Yoo KD, Jung KT, Cho YS, Lee HY, Youn TJ, Chung WY, Koo BK. Long-Term Clinical Outcomes of Fractional Flow Reserve-Guided Versus Routine Drug-Eluting Stent Implantation in Patients With Intermediate Coronary Stenosis: Five-Year Clinical Outcomes of DEFER-DES Trial. Circ Cardiovasc Interv. 2015 Dec;8(12):e002442. doi: 10.1161/CIRCINTERVENTIONS.115.002442.
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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.
Bon-Kwon Koo principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cypher, Taxus or Endeavor in people with Coronary Angiography and Drug-eluting Stents, 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 Dec 2010. 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.
Are results available for this study?
The study was stopped early (reason given: due to slow enrollment). Results are not available in the source record.
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?
Clinical event: Cardiac death, myocardial infarction, target lesion revascularization (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00592228, which also lists 1 linked publication.
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 21 Dec 2010.