FORMAT Clinical Study | NCT01804088

Studies
FORMAT Clinical Study

NCT01804088

Sponsor

Cook Group Incorporated

Status

Completed

Last Update Posted

Mar 1, 2018Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Symptomatic Vascular Disease of the Iliac Arteries

Interventions

Formula™ 535 Iliac Balloon-Expandable Stent

Countries

United States

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

Feb 2018

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 2013

Primary Completion Date

Apr 2015Actual

Completion Date

Jul 17, 2017Actual

First Submitted Date

Mar 1, 2013

First Submission Date that Met QC Criteria

Mar 1, 2013

First Posted Date

Mar 5, 2013Estimated

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

Feb 5, 2016

Certification/Extension First Submitted that Passed QC Review

Apr 6, 2016

Certification/Extension First Posted Date

May 4, 2016Estimated

Last Update Submitted Date

Feb 27, 2018

Last Update Posted Date

Mar 1, 2018Actual

Description Module

Brief Summary

The FORMAT Clinical Study is a clinical trial to evaluate the safety and effectiveness of the Formula™ 535 Iliac Balloon-Expandable Stent in treatment of symptomatic vascular disease of the iliac arteries.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stent	Experimental		Device: Formula™ 535 Iliac Balloon-Expandable Stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Formula™ 535 Iliac Balloon-Expandable Stent	Device	Treatment of symptomatic vascular disease of the iliac arteries	Stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Freedom from major adverse events		9 months

Secondary Outcomes

Measure	Description	Time Frame
Rate of technical success (i.e., successful delivery and deployment of a Formula™ 535 Iliac Balloon-Expandable Stent)		Intraoperative
Rate of acute procedure success(i.e.,vessel with <30% residual stenosis determined angiographically immediately after stent placement and no major clinical events)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Up to two documented common or external iliac artery lesions (one on each side), with >50% diameter stenosis, suitable for stenting
iliac artery reference vessel diameter of 5-10 mm
Rutherford Category 1, 2, 3, or 4.

Exclusion Criteria:

Less than 18 years of age
lesion site <10 or >100 mm in length
external iliac artery lesion visually estimated to be 100% occluded
presence of infrarenal aortic aneurysm >4 cm (treated or untreated)
presence of any aneurysm (treated or untreated) within target vessel
significant stenosis (>50%) or occlusion of inflow tract (infrarenal aortic lesions) not successfully treated before this procedure (success is measured as < 30% residual stenosis)
absence of at least one patent runoff vessel with ≤ 50% stenosis throughout its course (i.e., confirmed in-line patency to the level of the foot)
angiographically evident thrombus within the target vessel (treated or untreated)
lesion is in an iliac artery that has been previously stented

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
Patrick J. Geraghty, MD	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scripps Health		La Jolla	California	92037	United States
CardioVascular Solutions Institute

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