Tack Optimized Balloon Angioplasty (TOBA) Study | NCT01663818

Studies
Tack Optimized Balloon Angioplasty (TOBA) Study

NCT01663818

Sponsor

Philips Clinical & Medical Affairs Global

Status

Completed

Last Update Posted

Apr 5, 2021Actual

Enrollment

138Actual

Phase

Not Applicable

Conditions

Peripheral Vascular Disease

Interventions

Tack-It Endovascular Stapler

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Oct 2015Actual

First Submitted Date

Aug 6, 2012

First Submission Date that Met QC Criteria

Aug 9, 2012

First Posted Date

Aug 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2021

Last Update Posted Date

Apr 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Intact Vascular intends to conduct a prospective, single arm, 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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

138Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental	Treatment with Tack-IT Endovascular Staple	Device: Tack-It Endovascular Stapler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tack-It Endovascular Stapler	Device		Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety	Composite of new-onset major device-related adverse events.	30 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marc Bosiers, MD	St. Blasius Hospital	Principal Investigator
Dierk Scheinert, MD	Park Hospital, Leipzig	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Patrick Peeters, MD		Bonheiden		2820	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D016491	Peripheral Vascular Diseases

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided