NCT01663818

Brief Summary

A multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration 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

August 1, 2012

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

2.3 years

First QC Date

August 6, 2012

Last Update Submit

April 2, 2021

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

  • Safety

    Composite of new-onset major device-related adverse events.

    30 days

Study Arms (1)

Treatment group

EXPERIMENTAL

Treatment with Tack-IT Endovascular Staple

Device: Tack-It Endovascular Stapler

Interventions

Tack-It Endovascular StaplerDEVICE
Treatment group

Eligibility Criteria

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

You may qualify if:

  • Rutherford clinical category 2, 3 or 4
  • ABI less than or equal to 0.90
  • Reference vessel diameter is between 2.5mm and 5.5mm
  • Target lesion has stenosis greater than or equal to 70% or is occluded
  • Target lesion is less than or equal to 10cm in length

You may not qualify if:

  • Previously implanted stent in the ipsilateral superficial femoral or popliteal artery
  • Target treatment area is severly calcified (e.g. circumferential calcification or calcium plaque visible on plain fluoroscopy that extends far more than 5.0cm continuously)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patrick Peeters, MD

Bonheiden, 2820, Belgium

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Marc Bosiers, MD

    St. Blasius Hospital

    PRINCIPAL INVESTIGATOR

  • Dierk Scheinert, MD

    Park Hospital, Leipzig

    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 6, 2012

First Posted

August 13, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2014

Study Completion

October 1, 2015

Last Updated

April 5, 2021

Record last verified: 2021-04

Locations

BE(1)