Chronic Coronary OcclusionEXCELNCT01205789
EXCEL Clinical Trial (Universal Registry)
An observational study of Chronic Coronary Occlusion and Left Main Coronary Artery Disease, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Occlusion, Left Main Coronary Artery Disease, Stent Thrombosis
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 1000 consecutive subjects enrolled which includes approximately 100 consecutive subjects with intermediate lesions
Who may be able to join
- Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns.
Read the detailed description
Approximately 100 consecutive subjects who otherwise meet all enrollment criteria, will be analyzed separately as intermediate lesion subjects, and will be followed through the time of initial treatment per standard of care with intended PCI, CABG or medical treatment.
- Conditions
- Chronic Coronary Occlusion, Left Main Coronary Artery Disease, Stent Thrombosis, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Keywords
- Drug eluting stents, Stents, Angioplasty, Left Main Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease, Vascular Diseases, Myocardial Ischemia, Coronary Stenosis, Coronary Disease, Coronary Restenosis
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 |
|---|---|---|
| Universal Registry | Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study has no Primary outcome measure, it is an observational study to collect information on subjects not randomized to the RCT portion of the study.
The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns.
There are no follow-up time points for this study.
Measured: At the time of enrollment into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary OcclusionStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregg W Stone, MD, Principal investigator, Columbia UniversityPatrick W Serruys, MD, Principal investigator, Erasmus Medical CenterJoseph Sabik, MD, Principal investigator, Cleveland Clinical Main CampusA. Pieter Kappetein, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205789
- Sponsor's protocol ID
- 10-389 UR
- Acronym
- EXCEL
- Status last verified
- Nov 2012
- First submitted
- 16 Sep 2010
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXCEL Clinical Trial (Universal Registry)
- ClinicalTrials.gov ID
- NCT01205789
- Acronym / sponsor ID
- EXCEL / 10-389 UR
- Conditions
- Chronic Coronary Occlusion, Left Main Coronary Artery Disease, Stent Thrombosis, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis
- Keywords
- Drug eluting stents, Stents, Angioplasty, Left Main Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Sep 2010 (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 the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns.
Detailed description
Approximately 100 consecutive subjects who otherwise meet all enrollment criteria, will be analyzed separately as intermediate lesion subjects, and will be followed through the time of initial treatment per standard of care with intended PCI, CABG or medical treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Universal Registry | – | –Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 1000 consecutive subjects enrolled which includes approximately 100 consecutive subjects with intermediate lesions
Key inclusion criteria (1 listed)
- Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry
Key exclusion criteria (0 listed)
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
This study has no Primary outcome measure, it is an observational study to collect information on subjects not randomized to the RCT portion of the study.
Time frame: At the time of enrollment into the study
The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns. There are no follow-up time points for this study.
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 4 Dec 2012.
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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.
Gregg W Stone, MD principal investigator
Columbia University
Patrick W Serruys, MD principal investigator
Erasmus Medical Center
Joseph Sabik, MD principal investigator
Cleveland Clinical Main Campus
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 Chronic Coronary Occlusion and Left Main Coronary Artery Disease, run by Abbott Medical Devices at 1 site in United States.
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 0 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 4 Dec 2012. 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 United States. 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.
What does the primary outcome measure?
This study has no Primary outcome measure, it is an observational study to collect information on subjects not randomized to the RCT portion of the study. (time frame: At the time of enrollment into the study). 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 4 Dec 2012.