Bifurcating Coronary Artery LesionsPRESSURENCT00553670
Mechanism and Predictor of Side Branch Jailing
An observational study of Bifurcating Coronary Artery Lesions and Main Branch Stent Implantation, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Coronary artery bifurcation lesion is still one of the most challenging lesion subsets in the field of non-surgical treatment for a stenotic coronary artery. When one stent is placed in the main brach, it increases the side branch's stenosis degree. However, its mechanism and incidence are not known. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bifurcating Coronary Artery Lesions, Main Branch Stent Implantation, Side Branch Jailing
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2007to May 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bifurcating coronary artery lesion in left anterior descending coronary artery
Who may be able to join
- Elective coronary intervention (including stabilized ACS patients)
- Bifurcation lesion with TIMI 3 flow
- Side branch diameter > 2mm, side branch lesion length < 10mm by visual estimation
Who cannot join
- Left main coronary disease
- AMI, or Old MI at LAD territory
- LVEF < 40%, or other significant valvular or myocardial disease
- Significant side branch distal lesion
- Angiographically visible thrombus
- Heavily calcified lesion
- Side branch predilatation before main branch stent implantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictor and Mechanism of a Side Branch Jail After Main Branch Stent Implantation in Bifurcation Lesions
Coronary artery bifurcation lesion is still one of the most challenging lesion subsets in the field of non-surgical treatment for a stenotic coronary artery. When one stent is placed in the main brach, it increases the side branch's stenosis degree. However, its mechanism and incidence are not known. This study will be performed to search for the mechanism and incidence of that phenomenon.
- Keywords
- coronary artery, bifurcation, stent, intravascular ultrasound, fractional flow reserve
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 |
|---|---|---|
| 1 | Patients with elective coronary intervention for LAD-diagonal bifurcation lesion with provisional side branch intervention strategy with successful intravascular ultrasound and fractional flow reserve measurement |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startNov 2007
- Study completionMay 2009
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 Bifurcating Coronary Artery LesionsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Bon-Kwon Koo, PhD, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553670
- Sponsor's protocol ID
- H-0707-022-212
- Acronym
- PRESSURE
- Status last verified
- Mar 2011
- First submitted
- 1 Nov 2007
- Last updated
- 30 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koo BK, Waseda K, Kang HJ, Kim HS, Nam CW, Hur SH, Kim JS, Choi D, Jang Y, Hahn JY, Gwon HC, Yoon MH, Tahk SJ, Chung WY, Cho YS, Choi DJ, Hasegawa T, Kataoka T, Oh SJ, Honda Y, Fitzgerald PJ, Fearon WF. Anatomic and functional evaluation of bifurcation lesions undergoing percutaneous coronary intervention. Circ Cardiovasc Interv. 2010 Apr;3(2):113-9. doi: 10.1161/CIRCINTERVENTIONS.109.887406.
PubMed 20407111
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictor and Mechanism of a Side Branch Jail After Main Branch Stent Implantation in Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT00553670
- Acronym / sponsor ID
- PRESSURE / H-0707-022-212
- Keywords
- coronary artery, bifurcation, stent, intravascular ultrasound, fractional flow reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Study completion
- May 2009 (actual)
- First posted
- 5 Nov 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.
Coronary artery bifurcation lesion is still one of the most challenging lesion subsets in the field of non-surgical treatment for a stenotic coronary artery. When one stent is placed in the main brach, it increases the side branch's stenosis degree. However, its mechanism and incidence are not known. This study will be performed to search for the mechanism and incidence of that phenomenon.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with elective coronary intervention for LAD-diagonal bifurcation lesion with provisional side branch intervention strategy with successful intravascular ultrasound and fractional flow reserve measurement |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bifurcating coronary artery lesion in left anterior descending coronary artery
Key inclusion criteria (3 listed)
- Elective coronary intervention (including stabilized ACS patients)
- Bifurcation lesion with TIMI 3 flow
- Side branch diameter > 2mm, side branch lesion length < 10mm by visual estimation
Key exclusion criteria (7 listed)
- Left main coronary disease
- AMI, or Old MI at LAD territory
- LVEF < 40%, or other significant valvular or myocardial disease
- Significant side branch distal lesion
- Angiographically visible thrombus
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
Not reported in the source record.
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 30 Mar 2011.
- Derived from this study: PubMed 20407111Koo BK, Waseda K, Kang HJ, Kim HS, Nam CW, Hur SH, Kim JS, Choi D, Jang Y, Hahn JY, Gwon HC, Yoon MH, Tahk SJ, Chung WY, Cho YS, Choi DJ, Hasegawa T, Kataoka T, Oh SJ, Honda Y, Fitzgerald PJ, Fearon WF. Anatomic and functional evaluation of bifurcation lesions undergoing percutaneous coronary intervention. Circ Cardiovasc Interv. 2010 Apr;3(2):113-9. doi: 10.1161/CIRCINTERVENTIONS.109.887406.
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, PhD study director
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?
An observational study of Bifurcating Coronary Artery Lesions and Main Branch Stent Implantation, 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 3 inclusion and 7 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 30 Mar 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00553670, 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 30 Mar 2011.