RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU) (RE-GENERATION)

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.

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm; Aortic Aneurysm, Thoracic; Aorta, Thoracic Pathologies
• Intervention / Treatment: Device: Thoracic Endovascular Aortic Repair (TEVAR)

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relay Pro Device; The Relay Pro thoracic stent-graft will be used to treat pathologies eligible for thoracic endovascular aortic repair (TEVAR).	Device: Thoracic Endovascular Aortic Repair (TEVAR); thoracic endovascular repair (TEVAR) with a thoracic stent-graft; Other Names: RELAY PRO STENT GRAFT; RELAY NBS PRO STENT GRAFT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	30 days or less

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days after the procedure

Collaborators and Investigators

• Sponsor: Bolton Medical
• Investigators: Principal Investigator: Vicenç Riambau, Thorax Institute Hospital Clínic de Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2014
• Primary Completion (Actual): April 14, 2016
• Study Completion (Actual): April 30, 2016

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: IP-0011-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No