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Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection

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ClinicalTrials.gov Identifier: NCT03033043
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bolton Medical

Brief Summary:
This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.

Condition or disease Intervention/treatment Phase
Aortic Dissection Type B Device: Relay Pro Stent-Graft Not Applicable

Detailed Description:

This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.

Subjects will be enrolled on a first come, first serve basis; however, no single investigational site may enroll more than 20% of the proposed sample size of up to 80 subjects. A subject is considered enrolled when arterial access is gained and an attempt is made to introduce the RelayPro Thoracic Stent-Graft. Enrollment is expected to begin in mid-2016 and complete by the end of 2020.

All subjects enrolled, as defined above, will be included in the patient population for the primary safety analyses. All subjects implanted with the RelayPro Thoracic Stent-Graft will be included in the patient population for the primary effectiveness analyses.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 an Acute, Complicated Type B Aortic Dissection
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : May 17, 2019
Estimated Study Completion Date : April 17, 2024

Arm Intervention/treatment
Experimental: Experimental: Relay Pro
The Relay Pro arm includes subjects who receive the device. The Relay Pro Stent Graft System is administered to treat complicated Type B aortic dissections.
Device: Relay Pro Stent-Graft
Endovascular treatment of an aortic dissection
Other Name: Relay Pro Stent Graft System




Primary Outcome Measures :
  1. All-cause mortality post-procedure [ Time Frame: 30 days ]
    All-cause mortality 30 days post-procedure


Secondary Outcome Measures :
  1. Technical Success at the time of the index procedure [ Time Frame: During deployment of the device ]
    Successful delivery and deployment of the device, including withdrawal of the delivery system;

  2. Treatment success through 1 month [ Time Frame: 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite ]
    • Absence of Major adverse Event (MAE)
    • Absence of relevant MAEs:
    • Paraplegia;
    • Paraparesis;
    • New ischemia due to branch vessel compromise;
    • Absence of unintentional rupture of the dissection septum;

  3. Dissection Treatment Success [ Time Frame: 1, 6, and 12 month follow-up visits, and annually through 5 years. ]
    • Dissection treatment success through 1 month, 6 months, 12 months, and annually through 5 years, defined as individual endpoints and as a composite



Information from the National Library of Medicine

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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 have an acute (symptom onset to diagnosis within 2 weeks)or subacute, complicated type B aortic dissection (entire dissection is distal to the left subclavian artery (LSA)), confirmed by Computed Tomography Angiography (CTA) or Magnetic Resonance Angiogram (MRA), with time from symptom onset to diagnosis ≤ 6 weeks, with at least one of the following:

    • Malperfusion of the viscera, kidneys, spinal cord, or lower extremities, measured by clinical or radiographic evidence;
    • Rupture;
    • Intractable pain.
  • Proximal and distal aortic neck with diameter between 19 mm and 42 mm.
  • Subject's anatomy must meet all of the following anatomical criteria:

    1. Proximal attachment zone distal to the left common carotid and a distal attachment zone proximal to the origin of the celiac artery. (Dissection is permitted in the distal attachment zone but is not permitted in the proximal attachment zone.)
    2. The length of the attachment zones will depend on the intended stent-graft diameter and type of graft selected.
    3. The proximal attachment zone should be 15 mm for 22 - 28 mm RelayPro grafts with bare stent (20 mm for RelayPro grafts with non-bare stent), 20 mm for 30 - 46 mm RelayPro grafts with bare stent (25 mm for RelayPro grafts with non-bare stent), and proximal to non-dissected segment (healthy zone).
    4. The distal attachment zone should be 20 mm for all RelayPro grafts.
    5. Coverage of the left subclavian artery is permitted with mandatory revascularization if patent left internal mammary artery (LIMA) bypass or left upper extremity (LUE) arteriovenous graft or anomalous vertebral artery off the aorta. Revascularization must be performed prior to device placement, and may occur during implant procedure, provided it is before coverage of the LSA by the endograft.
  • Proximal attachment zone containing a straight segment (non-tapered, non-reverse-tapered, defined by <10% diameter change) with lengths equal to or greater than the required attachment length for the intended device.
  • Vascular dimensions (e.g., aortic diameters, length from left subclavian to celiac artery) must be in the range that can be safely treated with the RelayPro Thoracic Stent-Grafts.
  • Adequate iliac or femoral artery access for introduction of the RelayPro Delivery System. Alternative methods to gain proper access may be utilized (e.g., iliac conduit).
  • Subject willing to comply with the follow-up evaluation schedule.
  • Subject (or Legally Authorized Representative, LAR) agrees to sign an Informed Consent Form prior to treatment.

Exclusion Criteria:

  • Diagnosis of traumatic injury or transection of the descending thoracic aorta.
  • Significant stenosis, calcification, thrombus, or tortuosity of intended fixation sites that would compromise fixation or seal of the device.
  • Planned coverage of left carotid or celiac arteries; or anatomic variants that would compromise circulation to the carotid, vertebral, or innominate arteries after device placement, which is not amenable to subclavian revascularization.
  • Prior endovascular or surgical repair in the descending thoracic aorta. The device may not be placed within any prior endovascular or surgical graft.
  • Concomitant aneurysm/disease of the ascending aorta, aortic arch, or abdominal aorta, requiring repair. Dissection extension into the abdominal aorta is acceptable.
  • Prior abdominal aortic aneurysm repair (endovascular or surgical) that was performed less than 6 months prior to the planned stent implant procedure.
  • Major surgical or medical procedure within 30 days prior to the planned procedure, or is scheduled for a major surgical or medical procedure within 30 days post implantation. This excludes any planned procedures for the prospective stent-graft placement.
  • Untreatable allergy or sensitivity to contrast media or device components, including metal stents.
  • Known or suspected connective tissue disorder.
  • Blood coagulation disorder or bleeding diathesis for which the treatment cannot be suspended for one week pre- and/or post-repair.
  • Coronary artery disease with unstable angina.
  • Severe congestive heart failure (New York Heart Association functional class IV).
  • Stroke and/or Myocardial Infarction (MI) within 3 months of the planned treatment date.
  • Pulmonary disease requiring the routine (daily or nightly) need for oxygen therapy outside the hospital setting.
  • Acute renal failure or chronic renal insufficiency, and not receiving dialysis.
  • Hemodynamically unstable.
  • Active systemic infection and/or mycotic aneurysms.
  • Bowel necrosis.
  • Morbid obesity or other condition that may compromise or prevent the necessary imaging requirements.
  • ASA risk classification = V (Moribund patient not expected to live 24 hours with or without operation).
  • Less than two-year life expectancy.
  • Current or planned participation in an investigational drug or device study that has not completed primary endpoint evaluation.
  • Currently pregnant or planning to become pregnant during the course of the study.
  • Medical, social, or psychological issues that Investigator believes may interfere with treatment or follow-up.

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): NCT03033043


Contacts
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Contact: Lea Doyle 3523621021 LDoyle@BoltonMedical.com
Contact: Matthew Stark, Ph.D 954-626-5151 mstark@boltonmedical.com

  Show 22 Study Locations
Sponsors and Collaborators
Bolton Medical
Investigators
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Principal Investigator: Ed Y Woo, MD MedStar Regional Vascular Program.

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Responsible Party: Bolton Medical
ClinicalTrials.gov Identifier: NCT03033043     History of Changes
Other Study ID Numbers: IP-0017-16
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Bolton Medical:
aortic
dissection
type B
thoracic
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases