Thoracic DiseasesSURPASSNCT03286400
Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
An observational study of Thoracic Diseases, run by W.L.Gore & Associates at 20 sites in 7 countries.
Trial summary
Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Diseases
- Type of treatment
- Medical device
- How many people
- 127 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 18 Oct 2017to 9 Oct 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: All consecutive patients presenting with an indication for endovascular repair of the thoracic aorta are eligible for screening for participation in the registry. Only patients who meet all inclusion and no exclusion criteria, and who consent to participate will be enrolled.
Who may be able to join
- Age ≥ 18 years
- Signed informed consent form
- Willingness, in the opinion of the investigator, to adhere to standard of care follow-up requirements
- Surgical indication for TEVAR based on investigator's best medical judgment
- Intent to treat with CTAG Device with ACTIVE CONTROL.
Who cannot join
- Paraplegia or paraparesis at initial presentation
- Participation in concurrent research study or registry which may confound registry results, unless approved by Sponsor
- Prior implantation of a thoracic stent graft
- Pregnant or breast-feeding female at time of informed consent signature
- Life expectancy < 1 year due to comorbidities
Trial locations and contacts
20 sites in 7 countries.
20 sites in 7 countries
Germany4 sites
University Hospital Köln
Cologne
University of Heidelberg
Heidelberg
St. Franziskus Hospital GmbH
Münster
University Hospital Regensburg
Regensburg
Italy3 sites
Hospital Civili Brescia
Brescia
Ospedali dei Colli - Monaldi
Naples
Azienda Ospedaliers San Camilla Forlanni
Roma
Netherlands3 sites
University Hospital Amsterdam
Amsterdam
St Antonius Hospital
Nieuwegein
Erasmus Medical Center
Rotterdam
Spain3 sites
Hospital Universitario Central de Asturias
Oviedo
Hospital Clínico Santiago de Compostela
Santiago de Compostela
Hospital Universitario Miguel Servet
Zaragoza
United Kingdom3 sites
Leeds General Infirmary
Leeds
St George's Vascular Institute
London
St Thomas' London / Guy's Hospital
London
About this study
Official title: Observational Registry Characterizing the Performance and Feature Use of the GORE® TAG® Conformable Thoracic Stent Graft Featuring ACTIVE CONTROL System
Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice.
Read the detailed description
This is an observational, prospective, single-arm, post-market registry designed to collect real-world clinical and device specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice. A maximum of 20 clinical investigative sites in Europe will participate and up to 125 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the CTAG Device with ACTIVE CONTROL will be included and followed through one year per institutional standard of care.
- Conditions
- Thoracic Diseases
- Being tested
- CTAG Device with ACTIVE CONTROL
- Keywords
- CTAG, TEVAR
- Medical subject headings
- Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTAG Device with ACTIVE CONTROLDevice
Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| CTAG Device with ACTIVE CONTROL | All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL. Receives: Device: CTAG Device with ACTIVE CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Procedural Technical Success
Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion
Measured: 24 hours
Number of Subjects With Treatment Success at 30 Day Visit
Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration
Measured: One month
Secondary outcomes (8)
Number of Subjects With Freedom From Major Adverse Events at 30 Days
Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss
Measured: 30 Days
Number of Subjects With Freedom From Major Adverse Events at 12 Months
Freedom from: Lesion-related mortality, permanent paraplegia or paraparesis, disabling stroke, life-threatening myocardial infarction, new onset of renal failure, respiratory failure, life-threatening bowel ischemia, serious tissue ischemia, major blood loss
Measured: 12 Months
Number of Subjects With Treatment Success at 12 Month Visit
Technical Success and Freedom from: Type I or III endoleak, rupture of lesion within treated segment, stent graft occlusion, stent graft migration
Measured: One year
Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events
Freedom from incidence of Serious Adverse Events, other than Major Adverse Events, throughout the Registry Duration. Estimates determined from Kaplan-Meier analysis.
Measured: Days 30, 365, and 455
Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion
One year change from first post-implant CT scan in maximum aortic diameter
Measured: One year
Change in Maximum False Lumen Diameter Among Dissection
One year change from first post-implant CT scan in maximum false lumen diameter
Measured: One year
Change in Minimum True Lumen Diameter Among Dissection
One year change from first post-implant CT scan in minimum true lumen diameter
Measured: One year
Change in Maximum Aortic Diameter Among Dissection
One year change from first post-implant CT scan in maximum aortic diameter
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start18 Oct 2017
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe 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
- 127 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanni Torsello, MD, PhD, Principal investigator, St Franziskus Hospital GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286400
- Sponsor's protocol ID
- TAG 15-03
- Acronym
- SURPASS
- Status last verified
- Nov 2020
- First submitted
- 14 Sep 2017
- Last updated
- 17 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Torsello GF, Argyriou A, Stavroulakis K, Bosiers MJ, Austermann M, Torsello GB; SURPASS Registry Collaborators. One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System. J Endovasc Ther. 2020 Jun;27(3):421-427. doi: 10.1177/1526602820913007. Epub 2020 Mar 20.
PubMed 32193990
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Registry Characterizing the Performance and Feature Use of the GORE® TAG® Conformable Thoracic Stent Graft Featuring ACTIVE CONTROL System
- ClinicalTrials.gov ID
- NCT03286400
- Acronym / sponsor ID
- SURPASS / TAG 15-03
- Conditions
- Thoracic Diseases
- Keywords
- CTAG, TEVAR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Posted 17 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice.
Detailed description
This is an observational, prospective, single-arm, post-market registry designed to collect real-world clinical and device specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine clinical practice. A maximum of 20 clinical investigative sites in Europe will participate and up to 125 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the CTAG Device with ACTIVE CONTROL will be included and followed through one year per institutional standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTAG Device with ACTIVE CONTROL | – | Device: CTAG Device with ACTIVE CONTROLAll consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with CTAG Device with ACTIVE CONTROL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients presenting with an indication for endovascular repair of the thoracic aorta are eligible for screening for participation in the registry. Only patients who meet all inclusion and no exclusion criteria, and who consent to participate will be enrolled.
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Signed informed consent form
- Willingness, in the opinion of the investigator, to adhere to standard of care follow-up requirements
- Surgical indication for TEVAR based on investigator's best medical judgment
- Intent to treat with CTAG Device with ACTIVE CONTROL.
Key exclusion criteria (5 listed)
- Paraplegia or paraparesis at initial presentation
- Participation in concurrent research study or registry which may confound registry results, unless approved by Sponsor
- Prior implantation of a thoracic stent graft
- Pregnant or breast-feeding female at time of informed consent signature
- Life expectancy < 1 year due to comorbidities
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 |
|---|---|---|
| CTAG Device with ACTIVE CONTROLIntent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice. | Device | CTAG Device with ACTIVE CONTROL |
Primary outcome
Number of Subjects With Procedural Technical Success
Time frame: 24 hours
Successful access to the arterial system, successful deployment at the intended location, patent endoluminal graft, absence of surgical conversion
Number of Subjects With Treatment Success at 30 Day Visit
Time frame: One month
Technical Success and Freedom from: Type I or III endoleak, rupture of lesion in treated segment, stent graft occlusion, stent graft migration
8 secondary outcomes
Number of Subjects With Freedom From Major Adverse Events at 30 Days
Time frame: 30 Days
Number of Subjects With Freedom From Major Adverse Events at 12 Months
Time frame: 12 Months
Number of Subjects With Treatment Success at 12 Month Visit
Time frame: One year
Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events
Time frame: Days 30, 365, and 455
Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion
Time frame: One year
Change in Maximum False Lumen Diameter Among Dissection
Time frame: One year
Change in Minimum True Lumen Diameter Among Dissection
Time frame: One year
Change in Maximum Aortic Diameter Among Dissection
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32193990Torsello GF, Argyriou A, Stavroulakis K, Bosiers MJ, Austermann M, Torsello GB; SURPASS Registry Collaborators. One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System. J Endovasc Ther. 2020 Jun;27(3):421-427. doi: 10.1177/1526602820913007. Epub 2020 Mar 20.
- 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.
Giovanni Torsello, MD, PhD principal investigator
St Franziskus Hospital GmbH
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Diseases, run by W.L.Gore & Associates at 20 sites in 7 countries.
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 5 inclusion and 5 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, Italy, Netherlands, Spain, United Kingdom and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 17 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Procedural Technical Success (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 NCT03286400, 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 17 Dec 2020.