Chocolate Balloon Angioplasty Registry | NCT01589042

Studies
Chocolate Balloon Angioplasty Registry

NCT01589042

Sponsor

TriReme Medical, LLC

Status

Completed

Last Update Posted

Sep 11, 2018Actual

Enrollment

490Actual

Phase

Not provided

Conditions

Peripheral Arterial Disease

Interventions

Not provided

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

Sep 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

May 2012

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Apr 27, 2012

First Submission Date that Met QC Criteria

Apr 30, 2012

First Posted Date

May 1, 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

Sep 7, 2018

Last Update Posted Date

Sep 11, 2018Actual

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

To collect data from real-world use with the Chocolate PTA Balloon Catheter to support the effectiveness of the device for use during percutaneous transluminal angioplasty (PTA) procedures.

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

Not provided

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

490Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Above the Knee		Patients treated with the Chocolate balloon for a lesion located above the knee
Below the Knee		Patients treated with the Chocolate balloon for a lesion located below the knee

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Achievement of Optimal PTA	Percentage of PTA cases in which <30% diameter stenosis without a flow limiting dissection is achieved without the need for bail-out stenting	average of 2 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 years of age
Lesion successfully crossed with a guide-wire
Reference Vessel Diameter (RVD) within the treatment range of the Chocolate PTA Catheter used at the target lesion appropriate for 1:1 dilatation
Patient has given consent for their information to be submitted to this registry

Exclusion Criteria:

Lesion required stenting as the primary treatment approach
Life expectancy <12 months
Patient is enrolled in another clinical study that may impact the results of this registry

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

Patients with Peripheral Arterial Disease appropriate for treatment with balloon angioplasty

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jihad Mustapha, MD	Metro Health Hospital	Principal Investigator
Lawrence Garcia, MD	St Elizabeth's Med Center / Tufts Univ School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arizona Heart Institute		Phoenix	Arizona		United States
Desert Cardiology

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