Drug Eluting StentAIFSIDDESNCT00973375
Angiographic and Intravascular Ultrasound (IVUS) Follow-up After Simultaneously Implanted Different Drug-eluting Stents in Same Individuals
An observational study of Drug Eluting Stent, run by Liuhuaqiao Hospital at 1 site in China.
Trial summary
The purpose of this study is to investigate if there is any different follow-up results by angiography and IVUS between two different drug-eluting stents after implanted simultaneously in same individuals. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Drug Eluting Stent
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2009to not given
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: These patients who received two kinds of drug-eluting stent (Endeavor and Excel) im simultaneously.
Who may be able to join
- These patients who received two kinds of drug-eluting stent (Endeavor and Excel) im simultaneously.
Who cannot join
- Dual anti-platelet therapy less than 12 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liuhuaqiao Hospital
Guangzhou, Guangdong, 510010
Dingcheng Xiang, MD, Ph.D, +86-20-3665 3325, dcxiang@foxmail.com
Dingcheng Xiang, MD, Ph.D
About this study
The purpose of this study is to investigate if there is any different follow-up results by angiography and IVUS between two different drug-eluting stents after implanted simultaneously in same individuals.
- Conditions
- Drug Eluting Stent
- Keywords
- Drug-eluting stent, coronary restenosis, coronary thrombosis
- Medical subject headings
- Coronary Restenosis, Coronary Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endeavor group and Excel group | Endeavor group: measurements from the vessels implanted Endeavor stent(s). Excel group: measurements from the vessels implanted Excel stent(s). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segment and instent restenosis measured by coronary angiography and IVUS.
Measured: at 12 months after implantation
Secondary outcomes (1)
Uncovered and malposition of stent.
Measured: at 12 months after implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Drug Eluting StentStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liuhuaqiao Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973375
- Sponsor's protocol ID
- LHQ09-003
- Acronym
- AIFSIDDES
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Waseda K, Miyazawa A, Ako J, Hasegawa T, Tsujino I, Sakurai R, Yock PG, Honda Y, Kandzari DE, Leon MB, Fitzgerald PJ; ENDEAVOR IV Trial Investigators. Intravascular ultrasound results from the ENDEAVOR IV trial: randomized comparison between zotarolimus- and paclitaxel-eluting stents in patients with coronary artery disease. JACC Cardiovasc Interv. 2009 Aug;2(8):779-84. doi: 10.1016/j.jcin.2009.05.015.
PubMed 19695548Lee CH, Zhang J, Kailasam A, Tai BC, Ye F, Low AF, Hou X, Hay ET, Teo SG, Lim YT, Chen S, Tan HC. An intravascular ultrasound study of Cypher, Taxus, and endeavor stents on relation between neointimal proliferation and residual plaque burden. J Interv Cardiol. 2008 Dec;21(6):519-27. doi: 10.1111/j.1540-8183.2008.00397.x. Epub 2008 Oct 21.
PubMed 18973509Miyazawa A, Ako J, Hongo Y, Hur SH, Tsujino I, Courtney BK, Hassan AH, Kandzari DE, Honda Y, Fitzgerald PJ; ENDEAVOR III Investigators. Comparison of vascular response to zotarolimus-eluting stent versus sirolimus-eluting stent: intravascular ultrasound results from ENDEAVOR III. Am Heart J. 2008 Jan;155(1):108-13. doi: 10.1016/j.ahj.2007.08.008. Epub 2007 Sep 14.
PubMed 18082499
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiographic and Intravascular Ultrasound (IVUS) Follow-up After Simultaneously Implanted Different Drug-eluting Stents in Same Individuals
- ClinicalTrials.gov ID
- NCT00973375
- Acronym / sponsor ID
- AIFSIDDES / LHQ09-003
- Conditions
- Drug Eluting Stent
- Keywords
- Drug-eluting stent, coronary restenosis, coronary thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Liuhuaqiao HospitalUniversity, hospital or other
- Study start
- May 2009
- First posted
- 9 Sep 2009 (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 investigate if there is any different follow-up results by angiography and IVUS between two different drug-eluting stents after implanted simultaneously in same individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endeavor group and Excel group | – | –Endeavor group: measurements from the vessels implanted Endeavor stent(s). Excel group: measurements from the vessels implanted Excel stent(s). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- These patients who received two kinds of drug-eluting stent (Endeavor and Excel) im simultaneously.
Key inclusion criteria (1 listed)
- These patients who received two kinds of drug-eluting stent (Endeavor and Excel) im simultaneously.
Key exclusion criteria (1 listed)
- Dual anti-platelet therapy less than 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Segment and instent restenosis measured by coronary angiography and IVUS.
Time frame: at 12 months after implantation
1 secondary outcome
Uncovered and malposition of stent.
Time frame: at 12 months after implantation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2009.
- Background: PubMed 19695548Waseda K, Miyazawa A, Ako J, Hasegawa T, Tsujino I, Sakurai R, Yock PG, Honda Y, Kandzari DE, Leon MB, Fitzgerald PJ; ENDEAVOR IV Trial Investigators. Intravascular ultrasound results from the ENDEAVOR IV trial: randomized comparison between zotarolimus- and paclitaxel-eluting stents in patients with coronary artery disease. JACC Cardiovasc Interv. 2009 Aug;2(8):779-84. doi: 10.1016/j.jcin.2009.05.015.
- Background: PubMed 18973509Lee CH, Zhang J, Kailasam A, Tai BC, Ye F, Low AF, Hou X, Hay ET, Teo SG, Lim YT, Chen S, Tan HC. An intravascular ultrasound study of Cypher, Taxus, and endeavor stents on relation between neointimal proliferation and residual plaque burden. J Interv Cardiol. 2008 Dec;21(6):519-27. doi: 10.1111/j.1540-8183.2008.00397.x. Epub 2008 Oct 21.
- Background: PubMed 18082499Miyazawa A, Ako J, Hongo Y, Hur SH, Tsujino I, Courtney BK, Hassan AH, Kandzari DE, Honda Y, Fitzgerald PJ; ENDEAVOR III Investigators. Comparison of vascular response to zotarolimus-eluting stent versus sirolimus-eluting stent: intravascular ultrasound results from ENDEAVOR III. Am Heart J. 2008 Jan;155(1):108-13. doi: 10.1016/j.ahj.2007.08.008. Epub 2007 Sep 14.
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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?
An observational study of Drug Eluting Stent, run by Liuhuaqiao Hospital at 1 site in China.
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 1 inclusion and 1 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 9 Sep 2009. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Segment and instent restenosis measured by coronary angiography and IVUS. (time frame: at 12 months after implantation). 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 NCT00973375, which also lists 3 linked publications.
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 9 Sep 2009.