CClinicalTrials.gg
Sign In
CompletedNCT00646048AAA IDEUpdated Jan 28, 2011Results posted

A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms

A Phase 1 interventional study of TriVascular Stent-Graft System in Abdominal Aortic Aneurysm, sponsored by Boston Scientific Corporation. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-28.

Sponsored by Boston Scientific Corporation · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
43
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms. Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System, evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to exclude the abdominal aortic aneurysm.

02

Conditions studied

  • Abdominal Aortic Aneurysm

Keywords

  • Abdominal Aortic Aneurysm
  • AAA
  • TriVascular Stent-Graft System
  • Stent-Graft
03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's enrollment of 43 is below the median of 72 across 462 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or infertile female
  • Have signed an informed consent form.
  • Are considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm.
  • at least one of the following: Abdominal aortic aneurysm >= 4.5 cm in diameter; aneurysm has increased in size by 0.5cm in last 6 months; maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment; saccular aneurysm larger than 3 cm.
  • Have patent iliac or femoral arteries that allow endovascular access to the aneurysmal site with a 17F Delivery Catheter.

Exclusion criteria

Exclusion Criteria:

  • A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due to trauma.
  • A need for emergent surgery.
  • contraindication to undergoing angiography.
  • A Thoracic aortic aneurysm that requires treatment.
  • Presence of thrombus or atheroma in proximal aortic neck covering > 50% of the endoluminal surface.
  • Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to \<7mm.
  • Congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated(e.g. angiography or CT) prior to treatment.
  • Unstable angina
  • Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta.
  • Connective tissue disease (e.g., Marfan's or Ehlers-Danlos syndrome.)
  • Hypercoagulable state.
  • Contraindication for anticoagulation.
  • Acute renal failure.
  • Active systemic infection.
  • less than 18 years of age.
  • Life expectancy less than 1 year.
  • Current, or anticipated participation within 1 year, in another research study involving an investigational device or new drug (with the exception of participation in the Lifeline Registry of Endovascular Therapy).
  • Other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Arm 1

    This arm is for patient that receive the TriVascular Stent-Graft System.

    Device: TriVascular Stent-Graft System

Interventions

  • DeviceTriVascular Stent-Graft System

    TriVascular Stent-Graft System

06

What researchers measure

Primary outcomes

  1. Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.

    Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.

    Time frame: 1 month

  2. Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).

    A Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts.

    Time frame: 1 month

Secondary outcomes

  1. Number of Participants Who Achieve Technical Success of the Stent Graft System.

    Technical success was defined as successful introduction of the delivery catheter into the arterial system at the time of the study procedure and successful delivery/deployment of the stent graft system to the intended location with the absence of device related surgical conversion and intra-operative mortality. Device related surgical conversion is defined as the inability to deliver or deploy the stent graft system, then subsequently surgically treating the patient.

    Time frame: Post procedure

07

Results

Posted Jan 19, 2011

Participant flow

Participant flow — Overall Study
MilestoneTriVascular Stent Graft
Started43
Completed27
Not completed16

Outcome measures

PrimaryNumber of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.

Device related adverse events included, but were not limited to: Stent Graft Migration, Vessel dissection or perforation, stent graft occlusion, branch vessel occlusion, aneurysm rupture.

Time frame:
1 month
Reported as:
Number · Participants
Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.
ParticipantsTriVascular Stent Graft
Number of Participants Without a Device Related Adverse Events Within 1 Month of the Study Procedure.36
PrimaryNumber of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).

A Type I endoleak is a persistent perigraft channel of blood flow that develops due to inadequate or ineffective seal at the graft ends (attachment zones). A Type III endoleak occurs in the midgraft region due to leakage through a defect in the graft fabric or between the segments of a multisegmental graft. A Type IV endoleak is seen on completion of angiography or subsequent contrast studies as any blush of contrast that is presumed to emanate from blood diffusion across the porous graft fabric or through small holes in the graft cause by sutures or stent struts.

Time frame:
1 month
Reported as:
Number · Participants
Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).
ParticipantsTriVascular Stent Graft
Number of Participants Without a Type I, III, and/or IV Endoleak at 1 Month Follow-up Identified by Computed Tomography (CT).0
SecondaryNumber of Participants Who Achieve Technical Success of the Stent Graft System.

Technical success was defined as successful introduction of the delivery catheter into the arterial system at the time of the study procedure and successful delivery/deployment of the stent graft system to the intended location with the absence of device related surgical conversion and intra-operative mortality. Device related surgical conversion is defined as the inability to deliver or deploy the stent graft system, then subsequently surgically treating the patient.

Time frame:
Post procedure
Reported as:
Number · Participants
Number of Participants Who Achieve Technical Success of the Stent Graft System.
ParticipantsTriVascular Stent Graft
Number of Participants Who Achieve Technical Success of the Stent Graft System.42

Adverse events

Collected over Baseline through 5 year follow-up.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TriVascular Stent Graft—35/43 (81.4%)33/43 (76.7%)
Most frequent serious events
Showing 10 of 101
Most frequent serious events
EventTriVascular Stent Graft
Stent occlusionInjury, poisoning and procedural complications8/43
Stent-graft endoleakInjury, poisoning and procedural complications8/43
Device breakageInjury, poisoning and procedural complications7/43
Device failureInjury, poisoning and procedural complications6/43
PneumoniaInfections and infestations5/43
HypotensionVascular disorders5/43
Cardiac failure congestiveCardiac disorders4/43
Angina pectorisCardiac disorders3/43
Cardio-respiratory arrestCardiac disorders3/43
Myocardial infarctionCardiac disorders3/43
Most frequent other events
Most frequent other events
EventTriVascular Stent Graft
Device breakageInjury, poisoning and procedural complications12/43
Intermittent claudicationVascular disorders8/43
Back painMusculoskeletal and connective tissue disorders4/43
Catheter site haematomaGeneral disorders3/43
Catheter site related reactionGeneral disorders3/43
Stent-graft endoleakInjury, poisoning and procedural complications3/43

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)TriVascular Stent Graft
<=18 years0
Between 18 and 65 years4
>=65 years39
Age Continuous
Age Continuous(years)TriVascular Stent Graft
Mean73.1 ± 7.9
Sex: Female, Male
Sex: Female, Male(Participants)TriVascular Stent Graft
Female7
Male36
Region of Enrollment
Region of Enrollment(participants)TriVascular Stent Graft
United States43
08

Study locations

7 sites
  • Harbor UCLA Medical Center
    Torrance, California 90509, United States
  • Georgetown University Pasquerilla Healthcare
    Washington, District of Columbia 20007, United States
  • University of Florida - Shands Hospital
    Gainesville, Florida 32610, United States
  • Miami Cardiac & Vascular Institute Baptist Hospital
    Miami, Florida 33176, United States
  • Albany Medical College
    Albany, New York 12208, United States
  • University of Pennsylvania Medical Center
    Philadelphia, Pennsylvania 19104, United States
  • University of Pittsburgh Shadyside Hospital
    Pittsburgh, Pennsylvania 15232, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00646048
Lead sponsor
Boston Scientific Corporation
First posted
Mar 28, 2008
Start date
Feb 2003
Primary completion
Nov 2004
Completion
Mar 2010
Results posted
Jan 19, 2011
Last update
Jan 28, 2011

Study contacts

Pamela Grady, PhD
study director · Boston Scientific Corporation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Aneurysm→

Other studies from this sponsor

Boston Scientific Corporation

Start the discussion