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PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

Primary Purpose

Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PMEG

About this trial

This is an interventional treatment trial for Pararenal Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of signed and dated informed consent form
Male or female, aged ≥18 years
Expected survival beyond 1 year following successful aneurysm repair
Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and/or renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length
Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection
Adequate proximal zone of fixation
Adequate distal zone of fixation
No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm
Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary

Exclusion Criteria:

Moderate-to-severe aortic neck calcification, thrombus, or tortuosity
Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit
Proximal landing within zone 0 or 1
Inability to maintain at least one patent hypogastric artery
Freely ruptured aneurysm with hemodynamic instability
Non-ambulatory status
Severe CHF
Baseline eGFR < 30ml/min, unless currently on or to be initiating dialysis
Unstable angina
Stroke or MI within 3 months of planned treatment date
Active systemic infection and/or mycotic aneurysm
Uncorrectable coagulopathy or other bleeding diathesis
Known allergy to device material or contrast material that cannot be adequately pre-medicated
Body habitus that would preclude adequate fluoroscopic visualization of aorta
Pregnancy or lactation (confirmed per standard of care surgical practice)
Major, unrelated surgical procedure planned ≤30 days from endovascular repair
Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial
Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study
Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device
Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution

Sites / Locations

Tampa General HospitalRecruiting
University of South Florida - South Tampa CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physician-modified endografts

Arm Description

For this clinical protocol, endografts which are commercially available will be modified in a sterile fashion on a back-table in the operating room.

Outcomes

Primary Outcome Measures

Number of subjects with 30-day major adverse events from primary procedure

Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation >72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc

Number of subjects with treatment success

Secondary Outcome Measures

Number of subjects with mortality, major adverse events, spinal cord ischemia

Mortality includes all-cause mortality. Major adverse events include: aortic-related mortality, major stroke, myocardial Infarction, permanent spinal cord ischemia, renal failure, bowel Ischemia (requiring laparotomy/bowel resection), respiratory failure (mechanical ventilation >72 hours or requiring tracheostomy), lower extremity ischemia, blood loss ≥1,000cc. Spinal cord ischemia data will include all incidence and degree of spinal cord ischemia.

Number of subjects with treatment success and freedom from secondary intervention

Treatment success is defined as a composite of: technical success, device integrity (freedom from stent fractures), freedom from aortic enlargement ≥5mm compared to preoperative CT imaging, freedom from aortic rupture, freedom from reintervention for type I or III endoleak or patency-related event, freedom from conversion to open aneurysm repair, freedom from aneurysm-related mortality. Freedom from secondary interventions includes interventions to treat malperfusion, rupture, aneurysm formation, aortic expansion, endoleak, device stenosis/occlusion, or access site complication.

Full Information

NCT ID

NCT05195905

First Posted

January 4, 2022

Last Updated

July 25, 2023

Sponsor

Konstantinos Dean Arnaoutakis, MD

1. Study Identification

Unique Protocol Identification Number

NCT05195905

Brief Title

PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

Official Title

Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 6, 2023 (Actual)

Primary Completion Date

February 2029 (Anticipated)

Study Completion Date

August 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Konstantinos Dean Arnaoutakis, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Physician-modified endografts

Arm Type

Experimental

Arm Description

For this clinical protocol, endografts which are commercially available will be modified in a sterile fashion on a back-table in the operating room.

Intervention Type

Device

Intervention Name(s)

PMEG

Intervention Description

All devices that will be modified in this study protocol are commercially available in the United States. The commercially available endografts will be used to construct a fenestrated/branched device for this intervention.

Primary Outcome Measure Information:

Title

Number of subjects with 30-day major adverse events from primary procedure

Description

Time Frame

Day 30

Title

Number of subjects with treatment success

Description

Time Frame

Month 12

Secondary Outcome Measure Information:

Title

Number of subjects with mortality, major adverse events, spinal cord ischemia

Description

Time Frame

Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60

Title

Number of subjects with treatment success and freedom from secondary intervention

Description

Time Frame

Day 30, Month 6, Month 12, Month 24, Month 36, Month 48, Month 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of signed and dated informed consent form Male or female, aged ≥18 years Expected survival beyond 1 year following successful aneurysm repair Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and/or renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection Adequate proximal zone of fixation Adequate distal zone of fixation No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary Exclusion Criteria: Moderate-to-severe aortic neck calcification, thrombus, or tortuosity Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit Proximal landing within zone 0 or 1 Inability to maintain at least one patent hypogastric artery Freely ruptured aneurysm with hemodynamic instability Non-ambulatory status Severe CHF Baseline eGFR < 30ml/min, unless currently on or to be initiating dialysis Unstable angina Stroke or MI within 3 months of planned treatment date Active systemic infection and/or mycotic aneurysm Uncorrectable coagulopathy or other bleeding diathesis Known allergy to device material or contrast material that cannot be adequately pre-medicated Body habitus that would preclude adequate fluoroscopic visualization of aorta Pregnancy or lactation (confirmed per standard of care surgical practice) Major, unrelated surgical procedure planned ≤30 days from endovascular repair Patient is ≤30 days beyond primary endpoint for another investigative clinical drug/device trial Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beth Montera

Phone

8138447948

bmontera@usf.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Konstantinos Arnaoutakis, MD

arnaoutakis@usf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Konstantinos Arnaoutakis, MD

Organizational Affiliation

University of South Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tampa General Hospital

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beth Montera

Phone

813-844-7948

bmontera@usf.edu

First Name & Middle Initial & Last Name & Degree

Cara Grzybowski

Phone

813-844-7948

cgrzybowski@usf.edu

First Name & Middle Initial & Last Name & Degree

Konstantinos Arnaoutakis, MD

Facility Name

University of South Florida - South Tampa Campus

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beth Montera

Phone

813-844-7948

bmontera@usf.edu

First Name & Middle Initial & Last Name & Degree

Cara Grzybowski, BS

Phone

8138447873

cgrzybowski@usf.edu

First Name & Middle Initial & Last Name & Degree

Konstantinos Arnaoutakis, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29224942

Citation

Dossabhoy SS, Simons JP, Flahive JM, Aiello FA, Sheth P, Arous EJ, Messina LM, Schanzer A. Fenestrated endovascular aortic aneurysm repair using physician-modified endovascular grafts versus company-manufactured devices. J Vasc Surg. 2018 Jun;67(6):1673-1683. doi: 10.1016/j.jvs.2017.10.055. Epub 2017 Dec 8.

Results Reference

background

PubMed Identifier

30583902

Citation

Oderich GS, Ribeiro MS, Sandri GA, Tenorio ER, Hofer JM, Mendes BC, Chini J, Cha S. Evolution from physician-modified to company-manufactured fenestrated-branched endografts to treat pararenal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2019 Jul;70(1):31-42.e7. doi: 10.1016/j.jvs.2018.09.063. Epub 2018 Dec 21.

Results Reference

background

PubMed Identifier

26792544

Citation

Eagleton MJ, Follansbee M, Wolski K, Mastracci T, Kuramochi Y. Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2016 Apr;63(4):930-42. doi: 10.1016/j.jvs.2015.10.095. Epub 2016 Jan 11.

Results Reference

background

PubMed Identifier

28259577

Citation

Schanzer A, Simons JP, Flahive J, Durgin J, Aiello FA, Doucet D, Steppacher R, Messina LM. Outcomes of fenestrated and branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms. J Vasc Surg. 2017 Sep;66(3):687-694. doi: 10.1016/j.jvs.2016.12.111. Epub 2017 Mar 1.

Results Reference

background

PubMed Identifier

27986479

Citation

Oderich GS, Ribeiro M, Hofer J, Wigham J, Cha S, Chini J, Macedo TA, Gloviczki P. Prospective, nonrandomized study to evaluate endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts based on supraceliac sealing zones. J Vasc Surg. 2017 May;65(5):1249-1259.e10. doi: 10.1016/j.jvs.2016.09.038. Epub 2016 Dec 13.

Results Reference

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PubMed Identifier

17257941

Citation

Conrad MF, Crawford RS, Davison JK, Cambria RP. Thoracoabdominal aneurysm repair: a 20-year perspective. Ann Thorac Surg. 2007 Feb;83(2):S856-61; discussion S890-2. doi: 10.1016/j.athoracsur.2006.10.096.

Results Reference

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PubMed Identifier

17257942

Citation

Coselli JS, Bozinovski J, LeMaire SA. Open surgical repair of 2286 thoracoabdominal aortic aneurysms. Ann Thorac Surg. 2007 Feb;83(2):S862-4; discussion S890-2. doi: 10.1016/j.athoracsur.2006.10.088.

Results Reference

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PubMed Identifier

19362499

Citation

Schepens MA, Heijmen RH, Ranschaert W, Sonker U, Morshuis WJ. Thoracoabdominal aortic aneurysm repair: results of conventional open surgery. Eur J Vasc Endovasc Surg. 2009 Jun;37(6):640-5. doi: 10.1016/j.ejvs.2009.03.011. Epub 2009 Apr 11.

Results Reference

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PubMed Identifier

31727462

Citation

Arnaoutakis DJ, Scali ST, Beck AW, Kubilis P, Huber TS, Martin AJ, Laquian L, Back M, Giles KA, Fatima J, Beaver TM, Upchurch GR Jr. Comparative outcomes of open, hybrid, and fenestrated branched endovascular repair of extent II and III thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 May;71(5):1503-1514. doi: 10.1016/j.jvs.2019.08.236. Epub 2019 Nov 11.

Results Reference

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PubMed Identifier

29017806

Citation

Scali ST, Kim M, Kubilis P, Feezor RJ, Giles KA, Miller B, Fatima J, Huber TS, Berceli SA, Back M, Beck AW. Implementation of a bundled protocol significantly reduces risk of spinal cord ischemia after branched or fenestrated endovascular aortic repair. J Vasc Surg. 2018 Feb;67(2):409-423.e4. doi: 10.1016/j.jvs.2017.05.136. Epub 2017 Oct 7.

Results Reference

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PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm

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