Observational StudyNCT03869645
CAPERE Thrombectomy System Post-Market Clinical Follow Up Study
An observational study of Observational Study, run by Medtronic Endovascular at 3 sites in United States.
Trial summary
A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Observational Study
- What is being tested?
- CAPERE Thrombectomy System
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2019to 26 Aug 2020
- 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: Adult patients with clinical symptoms of extremity swelling with ultrasound evidence of acute thrombosis in the peripheral vasculature.
Who may be able to join
- Patients who are greater than or equal to 18 years of age
- Patients with clinical signs, symptoms and presentation consistent with acute thrombosis; onset of symptoms < 14 days
- Patients cleared medically for invasive endovenous procedures
Who cannot join
- Patients with IVC filter in area to be treated
- Patients who are < 18 years of age.
- Known anaphylactic reaction of radiographic contrast agents that cannot be pre- treated
- Imaging evidence or other evidence that suggests the participant is not appropriate for mechanical thrombectomy intervention
- Female who is pregnant or nursing
- Concurrent participation in another investigational drug or device treatment study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia
Charlottesville, Virginia, 22903
Memorial Health Services
Fountain Valley, California, 92708
St. Joseph Hospital
Orange, California, 92868
About this study
A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System.
Read the detailed description
A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System.
Subjects will be evaluated based on VEINES QoL survey pre- and post-treatment (30-days).
- Conditions
- Observational Study
- Being tested
- CAPERE Thrombectomy System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPERE Thrombectomy SystemDevice
Mechanical thrombectomy of acute thrombus in peripheral vasculature with the CAPERE Thrombectomy System
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of blood flow
Clearance of clot and restoration of venous flow of the affected vessel as confirmed using venogram immediately post-procedure
Measured: Day 0 - Intervention
Secondary outcomes (5)
Device Success
Successful withdrawal of device along with clots without clinically significant emboli, permanent vessel trauma, entry site aneurysm, major bleeding complications
Measured: Day 0
Technical Success Rate
Ratio of successful thrombus removals and total number of participants
Measured: Day 0
Thrombus removal rate
percent of thrombus removal comparing pre-treatment to post-treatment venography
Measured: Day 0
VEINES Survey
Evaluation of quality of life (QoL) before and after treatment based on VEINES survey responses. Eight (8) QoL questions related to the patient's leg problems are evaluated and their scores aggregated into a single QoL score. The resultant aggregated QoL range is from 26 - 108 where the higher the number the higher the quality of life.
Measured: </= Day 0 and Day 30
Safety Endpoint
Evaluation of the incidence of unanticipated adverse device events: estimated to be less than or equal to 5%
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Jun 2019
- Primary completion26 Aug 2020
- Study completion26 Aug 2020
Why it stopped: Change in Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Observational StudyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Endovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tiffany Wu, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869645
- Sponsor's protocol ID
- TP18-0009
- Status last verified
- Sep 2022
- First submitted
- 7 Mar 2019
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPERE Thrombectomy System Post-Market Clinical Follow Up Study
- ClinicalTrials.gov ID
- NCT03869645
- Acronym / sponsor ID
- TP18-0009
- Conditions
- Observational Study
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change in Sponsor
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medtronic EndovascularIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 11 Mar 2019 (actual)
- 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.
A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System.
Detailed description
A prospective, single-arm, non-blinded study, intending to collect and evaluate data in up to forty (40) human subjects with acute thrombosis, treated with the CAPERE™ Thrombectomy System.
Subjects will be evaluated based on VEINES QoL survey pre- and post-treatment (30-days).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with clinical symptoms of extremity swelling with ultrasound evidence of acute thrombosis in the peripheral vasculature.
Key inclusion criteria (3 listed)
- Patients who are greater than or equal to 18 years of age
- Patients with clinical signs, symptoms and presentation consistent with acute thrombosis; onset of symptoms < 14 days
- Patients cleared medically for invasive endovenous procedures
Key exclusion criteria (6 listed)
- Patients with IVC filter in area to be treated
- Patients who are < 18 years of age.
- Known anaphylactic reaction of radiographic contrast agents that cannot be pre- treated
- Imaging evidence or other evidence that suggests the participant is not appropriate for mechanical thrombectomy intervention
- Female who is pregnant or nursing
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 |
|---|---|---|
| CAPERE Thrombectomy SystemMechanical thrombectomy of acute thrombus in peripheral vasculature with the CAPERE Thrombectomy System | Device | – |
Primary outcome
Restoration of blood flow
Time frame: Day 0 - Intervention
Clearance of clot and restoration of venous flow of the affected vessel as confirmed using venogram immediately post-procedure
5 secondary outcomes
Device Success
Time frame: Day 0
Technical Success Rate
Time frame: Day 0
Thrombus removal rate
Time frame: Day 0
VEINES Survey
Time frame: </= Day 0 and Day 30
Safety Endpoint
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Change in Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Tiffany Wu, MD principal investigator
Unity Health Toronto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Observational Study, run by Medtronic Endovascular at 3 sites 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 3 inclusion and 6 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 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: Change in Sponsor). 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?
Restoration of blood flow (time frame: Day 0 - Intervention). 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 13 Sep 2022.