DEFINITIVE AR Two Year Follow-up Extension Study | NCT02363894

Studies
DEFINITIVE AR Two Year Follow-up Extension Study

NCT02363894

Sponsor

Medtronic Endovascular

Status

Completed

Last Update Posted

Feb 2, 2016Estimated

Enrollment

53Actual

Phase

Not provided

Conditions

Peripheral Arterial Disease

Interventions

Not provided

Countries

Not provided

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

Jan 2016

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

Mar 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Feb 10, 2015

First Submission Date that Met QC Criteria

Feb 10, 2015

First Posted Date

Feb 16, 2015Estimated

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

Feb 1, 2016

Last Update Posted Date

Feb 2, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this DEFINITIVE AR Two Year Follow-up Extension Study is to gather data to assess and estimate the long term effect of treating a vessel with plaque excision (PE) in combination with paclitaxel-coated balloon angioplasty (PTX PTA) compared to treatment with PTX PTA alone.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Label	Type	Description	Intervention Names
Subjects enrolled in DEFINITIVE AR

Measure	Description	Time Frame
Major Adverse Event Rate		2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Was a subject in DEFINITIVE AR I
Is able and willing to provide written informated consent prior to study specific data collection.

Exclusion Criteria:

Withdrew consent in DEFINITIVE AR I.
Was reported dead during DEFINITIVE AR I.

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

Subjects who participated in DEFINITIVE AR I and completed the 12 month follow-up assessment in DEFINITIVE AR.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prof. Thomas Zeller, MD	Universitats Herzzentrum Freiburg - Bad Krozingen, Germany	Principal Investigator
Prof. Gunnar Tepe, MD	Klinikum Rosenheim Institut fur Diagnostische und Interventionelle Radiologie - Rosenheim, Germany	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided