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CompletedNCT03286400SURPASSUpdated Dec 17, 2020Results posted

Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL

An observational study in Thoracic Diseases, sponsored by W.L.Gore & Associates. Completed at 20 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.

Sponsored by W.L.Gore & Associates · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
127
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Thoracic Diseases

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Keywords

  • CTAG
  • TEVAR
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  1. Age ≥ 18 years
  2. Signed informed consent form
  3. Willingness, in the opinion of the investigator, to adhere to standard of care follow-up requirements
  4. Surgical indication for TEVAR based on investigator's best medical judgment
  5. Intent to treat with CTAG Device with ACTIVE CONTROL.

Exclusion criteria

Exclusion Criteria:

  1. Paraplegia or paraparesis at initial presentation
  2. Participation in concurrent research study or registry which may confound registry results, unless approved by Sponsor
  3. Prior implantation of a thoracic stent graft
  4. Pregnant or breast-feeding female at time of informed consent signature
  5. Life expectancy \< 1 year due to comorbidities
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
127 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • 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.

    Device: CTAG Device with ACTIVE CONTROL

Interventions

  • DeviceCTAG Device with ACTIVE CONTROL

    Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 hours

  2. 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

    Time frame: One month

Secondary outcomes

  1. 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

    Time frame: 30 Days

  2. 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

    Time frame: 12 Months

  3. 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

    Time frame: One year

  4. 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.

    Time frame: Days 30, 365, and 455

  5. Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion

    One year change from first post-implant CT scan in maximum aortic diameter

    Time frame: One year

  6. Change in Maximum False Lumen Diameter Among Dissection

    One year change from first post-implant CT scan in maximum false lumen diameter

    Time frame: One year

  7. Change in Minimum True Lumen Diameter Among Dissection

    One year change from first post-implant CT scan in minimum true lumen diameter

    Time frame: One year

  8. Change in Maximum Aortic Diameter Among Dissection

    One year change from first post-implant CT scan in maximum aortic diameter

    Time frame: One year

06

Results

Posted Nov 17, 2020

Participant flow

Participant flow — Overall Study
MilestoneCTAG Device With ACTIVE CONTROL
Started127
Completed102
Not completed25
Withdrew: Death10
Withdrew: Lost to follow-up10
Withdrew: Physician decision1
Withdrew: Scheduling difficulty4

Outcome measures

PrimaryNumber 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

Time frame:
24 hours
Reported as:
Count of participants · Participants
Number of Subjects With Procedural Technical Success
ParticipantsCTAG Device With ACTIVE CONTROL
Number of Subjects With Procedural Technical Success123
PrimaryNumber 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

Time frame:
One month
Reported as:
Count of participants · Participants
Number of Subjects With Treatment Success at 30 Day Visit
ParticipantsCTAG Device With ACTIVE CONTROL
Number of Subjects With Treatment Success at 30 Day Visit115
SecondaryNumber 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

Time frame:
30 Days
Reported as:
Count of participants · Participants
Number of Subjects With Freedom From Major Adverse Events at 30 Days
ParticipantsCTAG Device With ACTIVE CONTROL
Number of Subjects With Freedom From Major Adverse Events at 30 Days105
SecondaryNumber 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

Time frame:
12 Months
Reported as:
Count of participants · Participants
Number of Subjects With Freedom From Major Adverse Events at 12 Months
ParticipantsCTAG Device With ACTIVE CONTROL
Number of Subjects With Freedom From Major Adverse Events at 12 Months90
SecondaryNumber 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

Time frame:
One year
Reported as:
Count of participants · Participants
Number of Subjects With Treatment Success at 12 Month Visit
ParticipantsCTAG Device With ACTIVE CONTROL
Number of Subjects With Treatment Success at 12 Month Visit97
SecondaryProbability 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.

Time frame:
Days 30, 365, and 455
Reported as:
Number · Probability
Probability of Freedom From Serious Adverse Events, Other Than Major Adverse Events
ProbabilityCTAG Device With ACTIVE CONTROL
30 Days0.826 (0.748 to 0.882)
365 Days0.699 (0.609 to 0.772)
455 Days0.628 (0.487 to 0.740)
SecondaryChange in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion

One year change from first post-implant CT scan in maximum aortic diameter

Time frame:
One year
Reported as:
Count of participants · Participants
Change in Maximum Aortic Diameter Among Aneurysm/Isolated Lesion
ParticipantsCTAG Device With ACTIVE CONTROL
>= 5mm Decrease20
No Change22
>= 5mm Increase5
SecondaryChange in Maximum False Lumen Diameter Among Dissection

One year change from first post-implant CT scan in maximum false lumen diameter

Time frame:
One year
Reported as:
Count of participants · Participants
Change in Maximum False Lumen Diameter Among Dissection
ParticipantsCTAG Device With ACTIVE CONTROL
>= 5mm Decrease15
No Change10
>= 5mm Increase1
SecondaryChange in Minimum True Lumen Diameter Among Dissection

One year change from first post-implant CT scan in minimum true lumen diameter

Time frame:
One year
Reported as:
Count of participants · Participants
Change in Minimum True Lumen Diameter Among Dissection
ParticipantsCTAG Device With ACTIVE CONTROL
>= 5mm Decrease5
No Change11
>= 5mm Increase10
SecondaryChange in Maximum Aortic Diameter Among Dissection

One year change from first post-implant CT scan in maximum aortic diameter

Time frame:
One year
Reported as:
Count of participants · Participants
Change in Maximum Aortic Diameter Among Dissection
ParticipantsCTAG Device With ACTIVE CONTROL
>= 5mm Decrease14
No Change10
>= 5mm Increase2

Adverse events

Collected over 455 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CTAG Device With ACTIVE CONTROL10/127 (7.9%)45/127 (35.4%)0/127 (0%)
Most frequent serious events
Showing 10 of 51
Most frequent serious events
EventCTAG Device With ACTIVE CONTROL
Stent-graft endoleakGeneral disorders9/127
Aortic aneurysmVascular disorders3/127
Aortic dissectionVascular disorders3/127
Myocardial infarctionCardiac disorders2/127
DeathGeneral disorders2/127
PneumoniaInfections and infestations2/127
SepsisInfections and infestations2/127
Urinary tract infectionInfections and infestations2/127
Vascular graft haemorrhageInjury, poisoning and procedural complications2/127
Vascular procedure complicationInjury, poisoning and procedural complications2/127

Baseline characteristics

Age, Continuous
Age, Continuous(Years)CTAG Device With ACTIVE CONTROL
Mean67.1 ± 12.1
Sex: Female, Male
Sex: Female, Male(Participants)CTAG Device With ACTIVE CONTROL
Female35
Male92
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)CTAG Device With ACTIVE CONTROL
Region of Enrollment
Region of Enrollment(participants)CTAG Device With ACTIVE CONTROL
Netherlands33
Sweden9
Italy24
United Kingdom5
France7
Germany39
Spain10
07

Study locations

20 sites
  • University Hospital Angers
    Angers, France
  • CHU Strasbourg
    Strasbourg, France
  • University of Heidelberg
    Heidelberg, Germany
  • University Hospital Köln
    Köln, Germany
  • St. Franziskus Hospital GmbH
    Münster, Germany
  • University Hospital Regensburg
    Regensburg, Germany
  • Hospital Civili Brescia
    Brescia, Italy
  • Ospedali dei Colli - Monaldi
    Napoli, Italy
  • Azienda Ospedaliers San Camilla Forlanni
    Roma, Italy
  • University Hospital Amsterdam
    Amsterdam, Netherlands
  • St Antonius Hospital
    Nieuwegein, Netherlands
  • Erasmus Medical Center
    Rotterdam, Netherlands
  • Hospital Universitario Central de Asturias
    Oviedo, Spain
  • Hospital Clínico Santiago de Compostela
    Santiago De Compostela, Spain
  • Hospital Universitario Miguel Servet
    Zaragoza, Spain
  • Uppsala University
    Uppsala, Sweden
  • Orebro University Hospital
    Örebro, Sweden
  • Leeds General Infirmary
    Leeds, United Kingdom
  • St George's Vascular Institute
    London, United Kingdom
  • St Thomas' London / Guy's Hospital
    London, United Kingdom
08

References and documents

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 documents

  • Study protocol · Apr 27, 2017
  • Statistical analysis plan · Jun 6, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03286400
Lead sponsor
W.L.Gore & Associates
Responsible party
Sponsor
First posted
Sep 18, 2017
Start date
Oct 18, 2017
Primary completion
Oct 9, 2019
Completion
Oct 9, 2019
Results posted
Nov 17, 2020
Last update
Dec 17, 2020

Study contacts

Giovanni Torsello, MD, PhD
principal investigator · St Franziskus Hospital GmbH

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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