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RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers (RelayPro-A)

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ClinicalTrials.gov Identifier: NCT02818972
Recruitment Status : Recruiting
First Posted : June 30, 2016
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Bolton Medical

Brief Summary:
Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.

Condition or disease Intervention/treatment Phase
Aortic Aneurysm, Thoracic Device: RelayPro Not Applicable

Detailed Description:
The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Non-Blinded, Non-Randomized Study of the RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RelayPro
Endovascular treatment with the investigational device.
Device: RelayPro
Endovascular treatment with investigational device.




Primary Outcome Measures :
  1. Rate of Major Adverse Events (MAEs) [ Time Frame: 30 days ]

    Primary safety endpoint is a composite of the following MAEs occurring through 30 days:

    • Death
    • Stroke (excluding transient ischemic attack)
    • Paralysis (excludes paraparesis)

  2. Technical success [ Time Frame: 24 hours ]

    Primary effectiveness rate as measured by the technical success through 24 hours, defined as:

    • Successful delivery of the device through the vasculature;
    • Successful deployment of the device at the intended location; Absence of Type I or III endoleaks; Patent stent-graft without significant stenosis.

  3. Stent graft patency [ Time Frame: 12 months ]
    Primary effectiveness as measured by the rate of stent-graft patency through 12 months.

  4. Aneurysm rupture [ Time Frame: 12 months ]
    Primary effectiveness as measured by the absence of aneurysm rupture through 12 months.

  5. Absence of Type I and III endoleak through 12 months; [ Time Frame: 12 months ]
    Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months.

  6. Absence of stent fractures in the attachment zone through 12 months [ Time Frame: 12 months ]
    Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months.

  7. Absence of open or endovascular secondary interventions [ Time Frame: 12 months ]
    Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months.

  8. Absence of aneurysm expansion (> 5 mm diameter increase) [ Time Frame: 12 months ]
    Primary effectiveness as measured by the absence of aneurysm expansion (> 5 mm diameter increase) through 12 months, compared to the first post-procedural computed tomographic (CT) imaging study.

  9. Absence of stent-graft migration [ Time Frame: 12 months ]
    Primary effectiveness as measured by the absence of stent-graft migration (> 10 mm) through 12 months, compared to the first post-procedural CT.


Secondary Outcome Measures :
  1. Loss of stent-graft patency [ Time Frame: 1 month and 6 months ]
    Loss of stent-graft patency will be assessed with CT scans, or MRIs for subjects unable to tolerate contrast media.

  2. Rate of aneurysm rupture [ Time Frame: 1 month and 6 months ]
    The rate of aneurysm rupture through 1 month and 6 months will be assessed by review of CT or MRI imaging, in addition to site reported adverse events.

  3. Rate of endoleaks of all types [ Time Frame: 1 month, 6 months and 12 months ]
    Persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft will be assessed by CT scans or MRIs for subjects unable to tolerate contrast media.

  4. Rate of stent fractures in the attachment zone [ Time Frame: 1 month and 6 months ]
    Stent fractures in the attachment zone will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media.

  5. Incidence of open or endovascular secondary interventions [ Time Frame: 1 month and 6 months ]
    Secondary effectiveness will be measured by the incidence of open or endovascular secondary interventions related to the device or treated pathology (ie, interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion).

  6. Rate of aneurysm expansion [ Time Frame: 1 month and 6 months ]
    The rate of aneurysm expansion (> 5 mm diameter increase) assessed by comparison of follow-up imaging to the first post-procedural CT

  7. Rate of stent-graft migration [ Time Frame: 1 month and 6 months ]
    The rate of stent-graft migration (> 10 mm) assessed by comparison of follow-up imaging to the first post-procedural CT.

  8. Individual outcomes of composite MAEs [ Time Frame: 6 months and 12 months ]
    Secondary effectiveness as measured by the individual outcomes of the composite safety endpoints (death, stroke, paralysis), as well as myocardial infarction (MI), renal failure, respiratory failure, bowel ischemia, and procedural blood loss >1,000 cc.

  9. Rate of vascular access complications [ Time Frame: During the initial implant attempt ]
    Secondary effectiveness as measured by the rate of vascular access complications reported during the Treatment visit (stent-graft implant). Outcome measures include successful delivery and deployment of the device, as well as withdrawal of the delivery system.

  10. Duration of implant procedure [ Time Frame: Treatment Visit ]
    Duration of the initial implant procedure captured as the number of minutes from introduction of device to removal of delivery system.

  11. Number of blood transfusions [ Time Frame: Treatment Visit through Discharge Visit ]
    Number of transfusions (units) required from the time of implant through hospital discharge.

  12. Duration of hospitalization [ Time Frame: Treatment Visit through Discharge Visit ]
    Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure.

  13. Time in Intensive Care Unit (ICU) [ Time Frame: Treatment Visit through Discharge Visit ]
    Duration of time in hours that subject was admitted to the Intensive Care Unit (ICU) following the implant procedure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must be ≥ 18 years of age
  • Subject has specified disease in his/her descending thoracic aorta.
  • Subject have anatomical compliance for the device specified for both access vessels and treatment area.
  • Subject must be willing to comply with the follow-up evaluation schedule.
  • Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment.

Exclusion Criteria:

  • Subject has specified disease of the thoracic aorta which is not included in the trial, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, ruptured aneurysm.
  • Subject anatomy with significant stenosis, calcification, thrombus or tortuosity.
  • Subjects with specified compromised circulation.
  • Subjects with specified prior procedures.
  • Subjects with allergy to contrast media or device components.
  • Subjects with disease, for example: suspected connective tissue disorder, specified coagulation disorders, specified coronary artery disease, severe congestive heart failure, stroke and/or Myocardial Infarction (MI) as specified, specified pulmonary disease, specified renal failure.
  • Subjects that are pregnant or planning to become pregnant during the course of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02818972


Contacts
Contact: Lea Doyle 352-362-1021 ldoyle@BoltonMedical.com

  Show 38 Study Locations
Sponsors and Collaborators
Bolton Medical
Investigators
Principal Investigator: Wilson Szeto, MD Penn Presbyterian
Principal Investigator: Venkatesh Ramaiah, MD Arizona Heart Institute

Responsible Party: Bolton Medical
ClinicalTrials.gov Identifier: NCT02818972     History of Changes
Other Study ID Numbers: IP-0015-16
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases