Physician Modified Endograft For Complex Aortic Aneurysm Repair

Conditions

• Complex Abdominal Aortic Aneurysm
• Juxtarenal Aortic Aneurysm
• Pararenal Aortic Aneurysm
• Thoracoabdominal Aortic Aneurysm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA). — DEVICE
  Modification * Deploy the graft on the sterile, surgical table * Mark out on the graft the locations of the fenestrations on the graft adjusting as necessary * Using handheld electrocautery, fashion the fenestration in the appropriate location on the moistened graft material in order to prevent inadvertent progression of the fenestration size * If the fenestration is going to remain as such, then a snare is used to fashion the marker on the fenestration with 5-0 stitch * If the fenestration is going to be made into a branch, then an appropriately sized, self-expanding stent is beveled and fashioned to be 15 mm long and sewn to the fenestration in addition to a snare with the 5-0 stitch * Two orientation markers are placed at the proximal edge and distal edge of the graft consisting of portions of the snare sewn to the anterior portion of the graft in a J fashion with a 5-0 stitch

Study Details

The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment. The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.

Key Dates

Start date

Mar 1, 2023

Status verified

May 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2029

Study Design

Enrollment

40 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Physician-Modified Endograft
  This is a single arm study used to evaluate the safety and effectiveness of fenestrated and branched techniques for the treatment of patients with a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysms (Extent I-V).

Primary Outcome Measure

The Primary Safety Endpoint (Freedom from major adverse events [MAE]) [ Time Frame: At 30 days or during hospitalization if this exceeds 30 days. ]

Central Contacts

• Sina Zarrintan, MD
  8582463003
  [email protected]
• Kathleen Groh
  8585348103
  [email protected]

Locations (1)

Find similar trials in San Diego, CA

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