Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies

June 28, 2024 updated by: Sukgu Han, MD, MS, University of Southern California

Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts

The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated/branched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).

Additionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Device Description

Two types of commercially approved thoracic aortic stent-grafts will be modified under the aegis of a physician-sponsored IDE protocol (G200159). The Cook (Bloomington, IN) Zenith Alpha proximal tapered mainbody thoracic stent-grafts and the Cook Zenith TX2 proximal tapered mainbody will be modified to form the fenestrated/branched aortic components. The Alpha thoracic stent-grafts are constructed of woven polyester graft sewn to discrete rows of self-expanding Nitinol Z stents. The most proximal sealing stent is located internally with fixation barbs that protrude through the graft material. The second proximal stent is straight, and the third stent is tapered by 4mm in diameter.

The diameter of the TX2 proximal tapered stent-grafts will range from 32mm to 42mm, depending on the size of the aorta at the proximal seal zone. The lengths will range from 154 to 210mm. The TX2 thoracic stent-grafts are constructed with woven polyester graft sewn to discrete rows of self-expanding stainless steel Z stents. The most proximal seal stent is sewn inside the polyester fabric. The third stent is tapered by either 4mm or 8mm in diameter.

The modification design will be planned using a 3-D multiplanar reconstruction analysis of the CT angiography. Proximal seal zone will be chosen at 2cm disease free parallel aortic walls. Target vessel position will be determined by the longitudinal distance between the proximal extent of the seal zone to the middle of the vessel orifice, as well as radial clock position. Based on these measurements, patient specific modification map will be constructed.

The modification will be designed to incorporate visceral and renal branches, utilizing a various combinations of fenestrations and branch cuffs. The choice between fenestrations and branch cuffs will be made based on the aortic size and angulation at the level of the target branches. For example, when the target branches are within the seal zone, fenestrations will be chosen. Conversely, branch cuffs will be incorporated onto the mainbody if the aorta at the level of the target branches is aneurysmal, or angulated where precise three dimensional position of the target branch, hence fenestration, along the implanted stent graft is difficult to predict.

Modification Technique

Modification will be performed on the day of the operation using strict sterile technique. Tapered low profile Cook Zenith Alpha proximal component thoracic stent grafts will be unsheathed. One of the trigger wires is retrieved from the inner cannula of the delivery system, to be used as a diameter constraining wire. This wire is rerouted posteriorly through and through the fabric of the stent graft using a long 22-gauge needle.

Fenestrations at planned locations will be created using an ophthalmic cautery, and reinforced with a double layer of Amplatz Gooseneck Snare (Medtronic, Minneapolis, MN) wires made up of braided Nitinol. The wires will be secured around the fenestration by tightly spaced 5-0 Ethibond (Ethicon, Somerville, NJ) locking sutures. Additional radiopaque markers will be sutured around each fenestration. When necessary, directional branch cuffs will be created by fashioning 8mm or 6mm Viabahn self expanding covered stents (Gore & Associates, Flagstaff, AZ) into 2cm long side branch cuffs. The branch cuffs will be sutured to the oval fenestration created on the aortic stent grafts by running 5-0 Goretex sutures. Radiopaque markers will be sutured around the entrance and exit of each branch cuff.

Prior to resheathing, the posterior aspect of Z-stents are constrained using loops of prolene sutures as diameter reducing ties. Proximal fixation barbs will be removed using a wire cutter. Fenestrations and branches designed to be catheterized from the brachial approach will be pre-wired with 0.014 inch guidewires. The modified stent graft will be resheathed using 2-0 Silk ties and Umbilical tapes.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment with fenestrated/branched stent grafts.

    1. Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the normal aortic diameter.
    2. Aneurysm with a history of growth ≥ 0.5cm per year.
    3. Saccular aneurysms deemed at significant risk for rupture based on physician interpretation.
    4. Symptomatic aneurysm without hemodynamic instability
    5. Aneurysms meeting any of the above criteria 1~4, above or below the previous endovascular and/or open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.

Exclusion Criteria:

  • Patients must be excluded from the study if any of the following conditions is true:

    1. Less than 18 years of age.
    2. Unwilling to comply with the follow-up schedule.
    3. Inability or refusal to give informed consent by the patient or a legally authorized representative.
    4. Pregnant or breastfeeding.
    5. Life-expectancy less than 2 years.
    6. Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol and performed remotely from the fenestrated procedure (>30 days). Examples include remote (>30days) participation in a thoracic, or abdominal branch device trial.
    7. Eligible for treatment with FDA-approved marketed device.
    8. Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PMEG FEVAR
The only arm of this study will be enrolled subjects who undergo physician modified endografting as a treatment of their thoracoabdominal aortic aneurysms or complex abdominal aortic aneurysms.
Device: Physician Modified Endografts

Modification procedure Description of modified device is detailed in Section 3.5 of IDE. In summary, the steps involved in modification of the Zenith Alpha thoracic stent grafts are;

  1. Unsheathing of the stent graft
  2. Retrieval of a trigger wire from the inner cannula of the delivery system
  3. Rerouting of the trigger wire along the stent graft
  4. Removal of proximal barbs.
  5. Creation of fenestrations and/or branch cuffs
  6. Placement of radiopaque markers around the fenestrations/ branch cuffs
  7. Placement of temporary and/or permanent diameter constraining ties
  8. (Optional) Placement of preloaded wires through the fenestrations/branch cuffs
Other Names:
  • Fenestrated, Branched Endografts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Major Adverse Events
Time Frame: Immediately after the surgery up to 30 days. If the hospital stay exceeds 30 days, major adverse events that occur prior to discharge from hospital will be included.
  1. Aortic rupture within 30 days
  2. Lesion-related mortality within 30 days
  3. All-cause mortality within 30 days
  4. Permanent paraplegia, defined by lack of resolution at 1 month follow-up
  5. Permanent paraparesis, defined by lack of resolution at 1 month follow-up
  6. Renal function decline resulting in > 50% of estimated Glomerular Filtration Rate or New onset renal failure requiring dialysis, defined by ongoing dialysis at 1 month follow-up
  7. Severe bowel ischemia, requiring laparotomy
  8. Disabling stroke, reported within 30 days of the procedure, without resolution at 90 days post-procedure
  9. Myocardial infarction
  10. Respiratory failure requiring prolonged (> 24 hours from anticipated) mechanical ventilation or reintubation
Immediately after the surgery up to 30 days. If the hospital stay exceeds 30 days, major adverse events that occur prior to discharge from hospital will be included.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Technical Success
Time Frame: Immediately after the surgery
Successful delivery of the device(s) to the intended target implantation site(s), and successful removal of the delivery system
Immediately after the surgery
Rate of Treatment Success
Time Frame: 30-days, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years

Treatment Success is defined by having met ALL of the following dichotomous conditions.

  • Technical success (Yes/No)
  • Absence of death form the initial procedure, secondary intervention for aortic-related cause (Yes/No)
  • Absence of persistent type I or III endoleaks (Yes/No)
  • Absence of aneurysm sac expansion > 5mm (Yes/No)
  • Absence of device migration > 10mm (Yes/No)
  • Absence of failure due to device integrity issues (Yes/No)
  • Absence of aneurysm rupture (Yes/No)
  • Absence of conversion to open surgical repair (Yes/No)
  • Absence of permanent paraplegia, disabling stroke, or dialysis that resulted from the initial operation or a secondary intervention to treat the original aortic pathology (Yes/No)
30-days, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Sukgu M Han, MD, MS, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2021

Primary Completion (Estimated)

July 2, 2028

Study Completion (Estimated)

July 2, 2032

Study Registration Dates

First Submitted

August 15, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APP-20-04282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Frailty Syndrome

Clinical Trials on Physician Modified Endografts

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe