Carotid Artery DiseaseCAPTURE 2NCT00302237
CAPTURE 2 Post-Marketing Registry
An observational study of Carotid Artery Disease, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The purposes of the registry are: 1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carotid Artery Disease
- What is being tested?
- RX ACCULINK, RX ACCUNET Embolic Protection System
- Type of treatment
- Medical device
- How many people
- 6,426 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to May 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Open-ended enrollment at approximately 400 clinical sites in the United States.
Who may be able to join
- Informed Consent for data collection.
- Intent to use the RX ACCULINK and RX ACCUNET to treat carotid artery disease.
Who cannot join
- none.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Second Phase of "Carotid RX ACCULINK/RX ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events"
The purposes of the registry are: 1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program.
Read the detailed description
CAPTURE 2 is an amendment to the CAPTURE study and will provide a mechanism for collection of data from the RX ACCULINK and RX ACCUNET Systems, when used by a broad group of physicians under commercial use conditions. The original CAPTURE study had built-in features that limited the ability to collect on-going real world data because it restricted the number of sites that could participate (up to 150 sites) and limited enrollment at each site (40 patients per site). CAPTURE 2 will not have these restrictions. CAPTURE 2 is a descriptive post-approval registry that will be conducted at approximately 400 clinical sites in the United States with open-ended enrollment. The purposes of this registry are: 1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System (EPS) can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program. As with the previous CAPTURE study, data will continue to be collected on any rare or unanticipated events that may occur. Patients in CAPTURE 2 will be followed after the index procedure to 30 days. During the 30 day follow-up period, any occurrence of death, stroke, myocardial infarction (MI), new neurologic events, and device-related adverse events will be reported to Abbott Vascular.
- Conditions
- Carotid Artery Disease
- Being tested
- RX ACCULINK, RX ACCUNET Embolic Protection System
- Keywords
- carotid, stenting, angioplasty
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RX ACCULINK, RX ACCUNET Embolic Protection SystemDevice
- To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program. Receives: Device: RX ACCULINK, RX ACCUNET Embolic Protection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of death, stroke, and MI (DSMI)
Measured: at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6,426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Gray, M.D., Study director, Executive Committee MemberJaysinghe Yadav, M.D., Study director, Executive Committee MemberRichard Atkinson, M.D., Study director, Executive Committee MemberRonald Fairman, M.D., Study director, Executive CommitteeMark Wholey, M.D., Study director, Executive Committee MemberRod Raabe, M.D., Study director, Executive Committee MemberRichard Green, M.D., Study director, Executive Committee MemberNick Hopkins, M.D., Study director, Executive Committee Member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302237
- Sponsor's protocol ID
- 05-716
- Acronym
- CAPTURE 2
- Status last verified
- Dec 2012
- First submitted
- 10 Mar 2006
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gray WA, Rosenfield KA, Jaff MR, Chaturvedi S, Peng L, Verta P; CAPTURE 2 Investigators and Executive Committee. Influence of site and operator characteristics on carotid artery stent outcomes: analysis of the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) clinical study. JACC Cardiovasc Interv. 2011 Feb;4(2):235-46. doi: 10.1016/j.jcin.2010.10.009.
PubMed 21349464Matsumura JS, Gray W, Chaturvedi S, Gao X, Cheng J, Verta P; CAPTURE 2 Investigators and Executive Committee. CAPTURE 2 risk-adjusted stroke outcome benchmarks for carotid artery stenting with distal embolic protection. J Vasc Surg. 2010 Sep;52(3):576-83, 583.e1-583.e2. doi: 10.1016/j.jvs.2010.03.064. Epub 2010 Jun 23.
PubMed 20576398
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Phase of "Carotid RX ACCULINK/RX ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events"
- ClinicalTrials.gov ID
- NCT00302237
- Acronym / sponsor ID
- CAPTURE 2 / 05-716
- Conditions
- Carotid Artery Disease
- Keywords
- carotid, stenting, angioplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,426 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 14 Mar 2006 (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 purposes of the registry are: 1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program.
Detailed description
CAPTURE 2 is an amendment to the CAPTURE study and will provide a mechanism for collection of data from the RX ACCULINK and RX ACCUNET Systems, when used by a broad group of physicians under commercial use conditions. The original CAPTURE study had built-in features that limited the ability to collect on-going real world data because it restricted the number of sites that could participate (up to 150 sites) and limited enrollment at each site (40 patients per site). CAPTURE 2 will not have these restrictions. CAPTURE 2 is a descriptive post-approval registry that will be conducted at approximately 400 clinical sites in the United States with open-ended enrollment. The purposes of this registry are: 1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System (EPS) can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program. As with the previous CAPTURE study, data will continue to be collected on any rare or unanticipated events that may occur. Patients in CAPTURE 2 will be followed after the index procedure to 30 days. During the 30 day follow-up period, any occurrence of death, stroke, myocardial infarction (MI), new neurologic events, and device-related adverse events will be reported to Abbott Vascular.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: RX ACCULINK, RX ACCUNET Embolic Protection System1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Open-ended enrollment at approximately 400 clinical sites in the United States.
Key inclusion criteria (2 listed)
- Informed Consent for data collection.
- Intent to use the RX ACCULINK and RX ACCUNET to treat carotid artery disease.
Key exclusion criteria (1 listed)
- none.
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 |
|---|---|---|
| RX ACCULINK, RX ACCUNET Embolic Protection System1) To provide an ongoing post-market surveillance mechanism to document clinical outcomes. 2) To provide additional information that the RX ACCULINK™ and RX ACCUNET™ can be used safely by a wide range of physicians under commercial use conditions. 3) To evaluate the adequacy of Abbott Vascular's physician training program. | Device | 1 |
Primary outcome
Composite of death, stroke, and MI (DSMI)
Time frame: at 30 days
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 13 Dec 2012.
- Derived from this study: PubMed 21349464Gray WA, Rosenfield KA, Jaff MR, Chaturvedi S, Peng L, Verta P; CAPTURE 2 Investigators and Executive Committee. Influence of site and operator characteristics on carotid artery stent outcomes: analysis of the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) clinical study. JACC Cardiovasc Interv. 2011 Feb;4(2):235-46. doi: 10.1016/j.jcin.2010.10.009.
- Derived from this study: PubMed 20576398Matsumura JS, Gray W, Chaturvedi S, Gao X, Cheng J, Verta P; CAPTURE 2 Investigators and Executive Committee. CAPTURE 2 risk-adjusted stroke outcome benchmarks for carotid artery stenting with distal embolic protection. J Vasc Surg. 2010 Sep;52(3):576-83, 583.e1-583.e2. doi: 10.1016/j.jvs.2010.03.064. Epub 2010 Jun 23.
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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.
William Gray, M.D. study director
Executive Committee Member
Jaysinghe Yadav, M.D. study director
Executive Committee Member
Richard Atkinson, M.D. study director
Executive Committee Member
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 Carotid 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 2 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: finished, as of the sponsor's last update on 13 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?
Composite of death, stroke, and MI (DSMI) (time frame: at 30 days). 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 NCT00302237, which also lists 2 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 13 Dec 2012; AzTrials last refreshed its copy on 30 Oct 2026.