Zilver® PTX™ Global Registry | NCT01094678

Studies
Zilver® PTX™ Global Registry

NCT01094678

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Sep 11, 2014Estimated

Enrollment

788Actual

Phase

Not Applicable

Conditions

Peripheral Arterial Disease
Peripheral Vascular Disease

Interventions

Zilver® PTX™ Stent

Countries

Germany
Italy

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

ID	Type	Description	Link
100010	Other Identifier	Cook

Status Module

Record Verification Date

Sep 2014

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

Apr 2006

Primary Completion Date

Jan 2009Actual

Completion Date

Apr 2011Actual

First Submitted Date

Mar 25, 2010

First Submission Date that Met QC Criteria

Mar 26, 2010

First Posted Date

Mar 29, 2010Estimated

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

Sep 9, 2014

Last Update Posted Date

Sep 11, 2014Estimated

Description Module

Brief Summary

The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.

Detailed Description

Not provided

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

788Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stent	Experimental		Device: Zilver® PTX™ Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zilver® PTX™ Stent	Device	Stenting of the superfemoropopliteal artery.	Stent

Measure	Description	Time Frame
Event-free Survival		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stenosis of the above-the-knee femoropopliteal artery
appropriate size and location of the lesion

Exclusion Criteria:

pregnant or breast feeding
failure or inability to give informed consent
simultaneously participating in another drug or device study

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
Michael Dake, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Heart Center Leipzig, Angiology		Leipzig		04289	Germany
St. Franziskus Hospital Munster

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33025243	Derived	Dake MD, Fanelli F, Lottes AE, O'Leary EE, Reichert H, Jiang X, Fu W, Iida O, Zen K, Schermerhorn M, Zeller T, Ansel GM. Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2021 Feb;44(2):196-206. doi: 10.1007/s00270-020-02648-6. Epub 2020 Oct 6.
23583245

ID	Term
D058729	Peripheral Arterial Disease
D016491	Peripheral Vascular Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases