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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03207568
Other study ID # IP-0011-14
Secondary ID
Status Completed
Phase N/A
First received June 30, 2017
Last updated June 30, 2017
Start date October 25, 2014
Est. completion date April 30, 2016

Study information

Verified date June 2017
Source Bolton Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 30, 2016
Est. primary completion date April 14, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design


Intervention

Device:
Thoracic Endovascular Aortic Repair (TEVAR)
thoracic endovascular repair (TEVAR) with a thoracic stent-graft

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bolton Medical

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
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