Back to resultsRE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU) (RE-GENERATION)
Primary Purpose
Aorta, Thoracic Pathologies, Aortic Aneurysm, Thoracic, Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thoracic Endovascular Aortic Repair (TEVAR)
Sponsored by
About this trial
This is an interventional treatment trial for Aorta, Thoracic Pathologies
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Relay Pro Device
Arm Description
The Relay Pro thoracic stent-graft will be used to treat pathologies eligible for thoracic endovascular aortic repair (TEVAR).
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03207568
Brief Title
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
Acronym
RE-GENERATION
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 25, 2014 (Actual)
Primary Completion Date
April 14, 2016 (Actual)
Study Completion Date
April 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bolton Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aorta, Thoracic Pathologies, Aortic Aneurysm, Thoracic, Aortic Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Relay Pro and Relay NBS Pro device
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Relay Pro Device
Arm Type
Experimental
Arm Description
The Relay Pro thoracic stent-graft will be used to treat pathologies eligible for thoracic endovascular aortic repair (TEVAR).
Intervention Type
Device
Intervention Name(s)
Thoracic Endovascular Aortic Repair (TEVAR)
Other Intervention Name(s)
RELAY PRO STENT GRAFT, RELAY NBS PRO STENT GRAFT
Intervention Description
thoracic endovascular repair (TEVAR) with a thoracic stent-graft
Primary Outcome Measure Information:
Title
Freedom from aneurysm or dissection-related mortality
Description
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).
Time Frame
30 days or less
Title
Delivery and deployment success evaluation
Description
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.
Time Frame
30 days or less
Secondary Outcome Measure Information:
Title
Major device-related adverse events (MAE)
Description
MAEs include:
Endoleak (types I, Ill and IV)
Stent migration (>10 mm)2
Lumen occlusion
Aorta rupture
Conversion to open repair
Time Frame
30 days after the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vicenç Riambau
Organizational Affiliation
Thorax Institute Hospital Clínic de Barcelona
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
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