NCT02101463

Brief Summary

This trial evaluates surgeon-modified fenestrated-branched stent-grafts (sm-FBSG) for Abdominal Aortic Aneurysms (AAA) that are custom-made intra-operatively with no waiting period by a qualified vascular surgeon. In addition, it aims to examine the alternative sm-FBSG for patients with restricted access to centers performing clinical trials with commercially available devices and those patients with aortic emergencies.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2015

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

2.9 years

First QC Date

March 25, 2014

Last Update Submit

November 13, 2019

Conditions

Complex Aortic Aneurysms

Keywords

aorticsm-FBSGaneurysmsfenestratedstent-graftsVascularEndovascular

Outcome Measures

Primary Outcomes (1)

  • Determine the safety and effectiveness of sm-FBSG for the treatment of complex aortic aneurysms in patients at high-risk for open surgical repair.

    Major adverse events defined as: * All-cause death * Bowel ischemia * Myocardial infarction * Paraplegia * Renal failure * Respiratory failure * Stroke * Blood loss \>=1,000cc The primary effectiveness endpoint is the proportion of treatment group subjects that achieve treatment success. Treatment success is a composite endpoint assessed at 12 months that includes successful delivery and deployment of the graft with branch vessel preservation (technical success) as well as freedom from Type 1 and 3 endoleaks, graft migration, and AAA enlargement or rupture. Technical success is defined as successful delivery and deployment of the physician modified endovascular graft with preservation of those branch vessels intended to be preserved. Includes freedom from the following at 12 months: Type I \& III endoleak, stent graft migration, AAA enlargement, AAA rupture and conversion to open repair through 12 months.

    30 Days

Secondary Outcomes (4)

  • Evaluate postoperative all-cause morbidity after repair with sm-FBSG

    >30 Days to 5 Years

  • Evaluate long-term survival and complications after repair of complex aortic aneurysms with sm-FBSG

    >30 Days to 5 Years

  • Successful device delivery and deployment with patency of all branches

    30 Days, 3 Months, 6 Months, and Years 1 to 5

  • Procedural / In-Hospital Evaluations

    30 Days

Study Arms (1)

surgeon-modified fenestrated-branched stent-grafts (sm-FBSG)

OTHER
Device: surgeon-modified fenestrated-branched stent-grafts (sm-FBSG)

Interventions

surgeon-modified fenestrated-branched stent-grafts (sm-FBSG)DEVICE
surgeon-modified fenestrated-branched stent-grafts (sm-FBSG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting for elective or urgent repair of a complex aortic aneurysm
  • No other investigational agents or devices while on protocol
  • Patient must be able and willing to comply with all follow-up exams
  • Life expectancy of more than 1 year
  • Patients with medical conditions that would make them unfit for open repair

You may not qualify if:

  • Estimated life expectancy \<1 year
  • Contraindication to angiography
  • Active infection
  • Patients with ruptured or contained ruptured aortic aneurysm who are persistently hemodynamically unstable at the time of presentation
  • Morbid Obesity with inability to visualize the aorta with available intraoperative imaging techniques

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Related Links

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Joseph J. Ricotta, II, MD, MS, FACS

    Northside Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2014

First Posted

April 2, 2014

Study Start

August 28, 2012

Primary Completion

July 31, 2015

Study Completion

December 8, 2015

Last Updated

November 15, 2019

Record last verified: 2019-11

Locations

US(1)