NCT01663064

Brief Summary

The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of abdominal aortic aneurysms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

3.3 years

First QC Date

August 2, 2012

Last Update Submit

July 30, 2020

Conditions

Aortic AneurysmAbdominal Aortic Aneurysm

Keywords

Abdominal aortic aneurysmEndovascularFenestrationJuxtarenalOff-the-shelfPararenal

Outcome Measures

Primary Outcomes (1)

  • Technical Success

    Technical success is described as: 1) successful access of the aneurysm site, 2) successful deployment of the Zenith® p-Branch™ endovascular graft in the intended location, 3) Zenith® p-Branch-™ endovascular graft is patent at deployment completion as evidenced by intraoperative angiography, and 4) all vessels targeted with a fenestration are patent at deployment completion as evidenced by intraoperative angiography.

    Up to 5 years

Study Arms (1)

Endovascular

EXPERIMENTAL

Endovascular treatment

Device: Endovascular treatment (Zenith® p-Branch™ endovascular graft)

Interventions

Endovascular treatment (Zenith® p-Branch™ endovascular graft)DEVICE

Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.

Endovascular

Eligibility Criteria

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

You may qualify if:

  • Pararenal or juxtarenal AAA \>5.0 cm in diameter
  • Pararenal or juxtarenal AAA with history of growth \>0.5 cm/year

You may not qualify if:

  • Age \< 18 years
  • Life expectancy \< 2 years
  • Pregnant or breast feeding
  • Inability or refusal to give informed consent by the patient or a legally authorized representative
  • Unwilling or unable to comply with the follow-up schedule
  • Additional medical restrictions as specified in the Clinical Investigation Plan
  • Additional anatomical restrictions as specified in the Clinical Investigation Plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skane University Hospital

Malmo, SE-205 02, Sweden

Location

MeSH Terms

Conditions

Aortic AneurysmAortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

AneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Timothy A. Resch, MD, PhD

    Skane University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 13, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2015

Study Completion

March 16, 2020

Last Updated

July 31, 2020

Record last verified: 2020-07

Locations

SE(1)