Drug-Coated Chocolate PTA Balloon in Patients With Periph... | NCT02129127

Studies
Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial

NCT02129127

Sponsor

TriReme Medical, LLC

Status

Completed

Last Update Posted

Apr 14, 2017Actual

Enrollment

67Actual

Phase

Not Applicable

Conditions

Peripheral Vascular Disease

Interventions

Paclitaxel Coated Chocolate Balloon Angioplasty

Countries

Germany
New Zealand

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 2017

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 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Apr 2017Actual

First Submitted Date

Apr 30, 2014

First Submission Date that Met QC Criteria

Apr 30, 2014

First Posted Date

May 2, 2014Estimated

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 12, 2017

Last Update Posted Date

Apr 14, 2017Actual

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

This first-in-man study is to evaluate the Drug-Coated Chocolate (DCC) Balloon for percutaneous arterial angioplasty in patients with symptomatic peripheral arterial disease. The study focuses on acute device performance and peri-procedural safety and also seeks to further characterize the performance of the device.

Detailed Description

This is a prospective, multi-center, single-arm study. Symptomatic lower extremity Peripheral Arterial Disease (PAD) patients presenting for endovascular revascularization will be enrolled in the study if they meet all entry criteria. The study will include patients from New Zealand and the European Union. The endpoints were designed to establish safety of the DCC and to identify long-term clinical benefits of this technology.

The patients treated in this study will be designated into the above the knee (ATK) follow-up schedule if they are treated with the DCC in the SFA or Popliteal vessels. This schedule calls for clinical visits with duplex ultrasounds at 1,6 and 12 months. Patients will be designated into the below the knee (BTK) follow-up schedule if they are treated with the DCC in the Peroneal, Anterior Tibial, Posterior Tibial or Pedal vessels. These patients will have clinical visits at 1, 3 and 6 months with duplex ultrasound at the 1 and 6 months visits only.

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

67Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Drug Coated Chocolate	Experimental	Paclitaxel Coated Chocolate Balloon Angioplasty	Device: Paclitaxel Coated Chocolate Balloon Angioplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paclitaxel Coated Chocolate Balloon Angioplasty	Device	Balloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel	Drug Coated Chocolate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Late Lumen Loss (LLL)	LLL is determined by assessing the difference between the minimum lumen diameter (MLD) immediately after treatment with the DCC and the MLD at angiographic follow-up. LLL will determined by the Angiographic Core Laboratory.	3 Months (BTK) or 6 Months (ATK)

Secondary Outcomes

Measure	Description	Time Frame
Device Success	This is defined as the percentage of procedures that accomplish less than 30% residual stenosis without flow-limiting dissection at target lesion after DCC treatment.	approx 1 hour
Technical Success

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Intermittent claudication or critical limb ischemia
Atherosclerotic target lesion >70% stenosis
Reference vessel diameter (RVD) between 2.0 and 6.0mm
Angiographic evidence of distal run-off
Target lesion length <150mm that consists of no more than two adjacent lesions( < 25mm apart) and is able to be completely covered with inflation of no more than two DCC devices

Key Exclusion Criteria:

Acute limb ischemia or thrombolytic therapy
Known and relevant allergies/hypersensitivities
Known impaired renal function
Known bleeding disorder
Severe calcification at the target lesion
Previous bypass or stent at, or proximal to, target vessel
Aneurysm in target limb
Prior major limb amputation
Use of a any of the following: re-entry device, atherectomy, laser or other ablation procedure, or cutting/scoring balloon at the target lesion; use of drug eluting stent, or non-study drug coated balloon in the target limb.

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
Andrew Holden, MD	Auckland City Hospital	Principal Investigator
Thomas Zeller, MD	Universitats Herzzentrum Bad Krozingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitats Herzzentrum Bad Krozingen		Bad Krozingen			Germany
Auckland City Hospital

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases