Aorta, Thoracic PathologiesRE-GENERATIONNCT03207568
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
A study testing Thoracic Endovascular Aortic Repair (TEVAR) in people with Aorta, Thoracic Pathologies and Aortic Aneurysm, Thoracic, run by Bolton Medical.
Trial summary
The objective of the study is to evaluate the safety and performance of Relay Pro and Relay NBS Pro devices in humans having thoracic aortic pathologies. Clinical results will be used to apply for the CE certification. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aorta, Thoracic Pathologies, Aortic Aneurysm, Thoracic, Aortic Aneurysm
- What is being tested?
- Thoracic Endovascular Aortic Repair (TEVAR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2014to 30 Apr 2016
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with thoracic aorta pathology (aneurysm, pseudoaneurysm, dissection, penetrating ulcer or intramural hematoma) suitable for TEVAR with a Relay Pro or Relay NBS Pro stent-graft; diagnosis must be confirmed by contrast computed tomography angiography (CTA) or magnetic resonance imaging (MRI) within 3 months of the planned implant procedure.
- Proximal and distal aortic necks suitable for stent-graft placement (i.e., diameter ranging between 18 and 42 mm)
- Proximal and distal landing zones suitable for the stent-graft
- Adequate vascular access for insertion of the delivery system, i.e., femoral or iliac arteries a minimum 6 mm in diameter to accommodate the 19 to 22-Fr outer-diameter delivery system and no excessive disease precluding delivery system entry/passage or iliac arteries that could be extended via an access conduit.
- Written informed consent provided by the subject him/herself (not a representative) upon enrollment
Who cannot join
- Patients who meet one or more of the following criteria are not eligible:
- Aneurysm/lesion location not accessible to the delivery system and stent placement
- Arterial access size insufficient for delivery system entrance or impossibility to perform a surgical access conduit
- Treatment of lesion that would require a delivery system with usable length greater than 90 cm
- Excessive arterial disease precluding delivery system entrance or passage
- Systemic infection
Show all 24Show fewer
- Arterial tortuosity not allowing passage of the delivery system
- Arterial or aneurysm/lesion size incompatible with stent graft
- Has congenital connective tissue disease rendering the aneurysm/lesion untreatable
- Mycotic aneurysm/lesions
- Aortic inner diameter that cannot accommodate the expanded Inner Secondary Sheath outer diameter of approximately 10mm
- Native bleeding diathesis
- Any condition (medical or anatomic) which makes the patient not suitable for endovascular
- repair according to the opinion of the investigator
- Untreatable allergy or history of allergic reaction to radiographic contrast medium
- Untreatable allergy or history of allergic reaction to anticoagulants
- Hypersensitivity to polyester or nitinol or any of the components of the Relay device
- Patient underwent prior thoracic aortic repair (endovascular or surgical)
- Participation in an investigational clinical study involving a new chemical entity or medical device within 3 months or 1 year, respectively, prior to the planned procedure
- Patient not willing to give consent for transmission of personal "pseudonymised" data
- For females: pregnancy or lactation
- Women of childbearing potential (not postmenopausal or surgically sterile) not willing to use an effective method of contraception during the study. Effective methods are hormonal contraceptives (e.g., oral, implanted, or injected), intrauterine device (IUDs), and sexual abstinence.
- Patient committed to an institution by virtue of an order issued either by the courts or by an authority
- Patient who is unable to comply with the requirements of the study or who in the opinion of theinvestigator should not participate in the study.
About this study
Official title: RE-GENERATION: An EU Clinical Study to Evaluate the Safety and Performance of the Relay Pro and Relay Non Bare Stent (NBS) Pro Stent-graft Devices in Patients With Thoracic Aortic Pathologies
The objective of the study is to evaluate the safety and performance of Relay Pro and Relay NBS Pro devices in humans having thoracic aortic pathologies.
Clinical results will be used to apply for the CE certification.
Read the detailed description
This is a prospective, multicenter, non-randomized, single arm clinical study in patients presenting thoracic aortic pathologies. Patients with thoracic aortic pathologies who are planned to undergo thoracic endovascular aortic repair (TEVAR) with a stent-graft based on routine clinical assessments performed as part of the patients' standard care will be screened after obtaining the informed consent from the patients, and if eligible, enrolled and scheduled for the implantation procedure with the study device.
Following a baseline assessment, the implantation procedure will be performed according to the Instructions for Use and local routine practice. A follow-up visit will be performed 30 days after the implantation procedure. The investigator will perform assessments of the implantation procedure and device system and document adverse events and device deficiencies.
- Being tested
- Thoracic Endovascular Aortic Repair (TEVAR)
- Medical subject headings
- Aortic Aneurysm, Thoracic, Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Endovascular Aortic Repair (TEVAR)Device
Also called RELAY PRO STENT GRAFT, RELAY NBS PRO STENT GRAFT
thoracic endovascular repair (TEVAR) with a thoracic stent-graft
| Study group | Role | What they receive |
|---|---|---|
| Relay Pro Device | Experimental | The Relay Pro thoracic stent-graft will be used to treat pathologies eligible for thoracic endovascular aortic repair (TEVAR). Receives: Device: Thoracic Endovascular Aortic Repair (TEVAR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from aneurysm or dissection-related mortality
All deaths due to the treated pathology, including aneurysm rupture, complications of TEVAR leading to new aortic pathology (e.g., retrograde dissection leading to fatal cardiac tamponade).
Measured: 30 days or less
Delivery and deployment success evaluation
Success will be based on the Delivery system evaluation, overall rate of vascular access complications
- Rate of access failures
- Rate of deployment system difficulties will be analyzed descriptively.
Measured: 30 days or less
Secondary outcomes (1)
Major device-related adverse events (MAE)
MAEs include:
- Endoleak (types I, Ill and IV)
- Stent migration (>10 mm)2
- Lumen occlusion
- Aorta rupture
- Conversion to open repair
Measured: 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start25 Oct 2014
- Primary completion14 Apr 2016
- Study completion30 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aorta, Thoracic PathologiesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Relay Pro and Relay NBS Pro device
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bolton Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vicenç Riambau, Principal investigator, Thorax Institute Hospital Clínic de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03207568
- Sponsor's protocol ID
- IP-0011-14
- Acronym
- RE-GENERATION
- Status last verified
- Jun 2017
- First submitted
- 30 Jun 2017
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RE-GENERATION: An EU Clinical Study to Evaluate the Safety and Performance of the Relay Pro and Relay Non Bare Stent (NBS) Pro Stent-graft Devices in Patients With Thoracic Aortic Pathologies
- ClinicalTrials.gov ID
- NCT03207568
- Acronym / sponsor ID
- RE-GENERATION / IP-0011-14
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bolton MedicalIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2014 (actual)
- Primary completion
- 14 Apr 2016 (actual)
- Study completion
- 30 Apr 2016 (actual)
- First posted
- 5 Jul 2017 (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.
The objective of the study is to evaluate the safety and performance of Relay Pro and Relay NBS Pro devices in humans having thoracic aortic pathologies.
Clinical results will be used to apply for the CE certification.
Detailed description
This is a prospective, multicenter, non-randomized, single arm clinical study in patients presenting thoracic aortic pathologies. Patients with thoracic aortic pathologies who are planned to undergo thoracic endovascular aortic repair (TEVAR) with a stent-graft based on routine clinical assessments performed as part of the patients' standard care will be screened after obtaining the informed consent from the patients, and if eligible, enrolled and scheduled for the implantation procedure with the study device.
Following a baseline assessment, the implantation procedure will be performed according to the Instructions for Use and local routine practice. A follow-up visit will be performed 30 days after the implantation procedure. The investigator will perform assessments of the implantation procedure and device system and document adverse events and device deficiencies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Relay Pro and Relay NBS Pro device
| Arm | Type | Receives |
|---|---|---|
| Relay Pro Device | Experimental | Device: Thoracic Endovascular Aortic Repair (TEVAR)The Relay Pro thoracic stent-graft will be used to treat pathologies eligible for thoracic endovascular aortic repair (TEVAR). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient diagnosed with thoracic aorta pathology (aneurysm, pseudoaneurysm, dissection, penetrating ulcer or intramural hematoma) suitable for TEVAR with a Relay Pro or Relay NBS Pro stent-graft; diagnosis must be confirmed by contrast computed tomography angiography (CTA) or magnetic resonance imaging (MRI) within 3 months of the planned implant procedure.
- Proximal and distal aortic necks suitable for stent-graft placement (i.e., diameter ranging between 18 and 42 mm)
- Proximal and distal landing zones suitable for the stent-graft
- Adequate vascular access for insertion of the delivery system, i.e., femoral or iliac arteries a minimum 6 mm in diameter to accommodate the 19 to 22-Fr outer-diameter delivery system and no excessive disease precluding delivery system entry/passage or iliac arteries that could be extended via an access conduit.
- Written informed consent provided by the subject him/herself (not a representative) upon enrollment
Key exclusion criteria (24 listed)
- Aneurysm/lesion location not accessible to the delivery system and stent placement
- Arterial access size insufficient for delivery system entrance or impossibility to perform a surgical access conduit
- Treatment of lesion that would require a delivery system with usable length greater than 90 cm
- Excessive arterial disease precluding delivery system entrance or passage
- Systemic infection
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 |
|---|---|---|
| Thoracic Endovascular Aortic Repair (TEVAR)Also: RELAY PRO STENT GRAFT, RELAY NBS PRO STENT GRAFTthoracic endovascular repair (TEVAR) with a thoracic stent-graft | Device | Relay Pro Device |
Primary outcome
Freedom from aneurysm or dissection-related mortality
Time frame: 30 days or less
All deaths due to the treated pathology, including aneurysm rupture, complications of TEVAR leading to new aortic pathology (e.g., retrograde dissection leading to fatal cardiac tamponade).
Delivery and deployment success evaluation
Time frame: 30 days or less
Success will be based on the Delivery system evaluation, overall rate of vascular access complications * Rate of access failures * Rate of deployment system difficulties will be analyzed descriptively.
1 secondary outcome
Major device-related adverse events (MAE)
Time frame: 30 days after the procedure
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 5 Jul 2017.
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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.
Vicenç Riambau principal investigator
Thorax Institute Hospital Clínic de Barcelona
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Endovascular Aortic Repair (TEVAR) in people with Aorta, Thoracic Pathologies and Aortic Aneurysm, Thoracic, run by Bolton Medical.
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 24 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 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Freedom from aneurysm or dissection-related mortality (time frame: 30 days or less). 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?
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 5 Jul 2017.