Nectero EAST System Clinical Study

Conditions

• Abdominal Aortic Aneurysm

Eligibility Criteria

Sex

ALL

Age

21 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Nectero EAST System — DRUG
  Treated subjects will undergo an endovascular procedure with the Nectero EAST system and receive the Stabilizer Infusion Solution (drug) within 30 days of the study eligibility by CT scan as a one-time local delivery of the drug.

Study Details

The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30/60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.

Key Dates

Start date

Oct 25, 2023

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Dec 31, 2032

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Arm
  Participants assigned to the treatment arm will undergo an endovascular procedure using the Nectero EAST System to deliver the Stabilizer Infusion Solution directly inside the aneurysm. This is a one-time local delivery of the product. Following treatment, surveillance of their AAA will be conducted using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years. Intervention: Drug: Stabilizer
• No Intervention: Control Arm
  Participants assigned to the control arm will undergo surveillance of their AAA using CT scans at 6 months, 12 months, 18 months, 24 months, and annually for 5 years.

Primary Outcome Measure

Primary Endpoint [ Time Frame: 24 months ]

Central Contacts

• Charlene Knape
  866-755-4744
  [email protected]
• Tracy Roberts
  (303)3964603
  [email protected]

Locations (37)

Find similar trials in Scottsdale, AZ

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