NCT03207568

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 25, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2016

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
Last Updated

July 5, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

June 30, 2017

Last Update Submit

June 30, 2017

Conditions

Aorta, Thoracic PathologiesAortic Aneurysm, ThoracicAortic Aneurysm

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Major device-related adverse events (MAE)

    30 days after the procedure

Study Arms (1)

Relay Pro Device

EXPERIMENTAL

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)

Interventions

Thoracic Endovascular Aortic Repair (TEVAR)DEVICE

thoracic endovascular repair (TEVAR) with a thoracic stent-graft

Also known as: RELAY PRO STENT GRAFT, RELAY NBS PRO STENT GRAFT
Relay Pro Device

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Aneurysm, ThoracicAortic Aneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Study Officials

  • Vicenç Riambau

    Thorax Institute Hospital Clínic de Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Relay Pro and Relay NBS Pro device
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 5, 2017

Study Start

October 25, 2014

Primary Completion

April 14, 2016

Study Completion

April 30, 2016

Last Updated

July 5, 2017

Record last verified: 2017-06