The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02129127




Registration number
NCT02129127
Ethics application status
Date submitted
30/04/2014
Date registered
2/05/2014
Date last updated
14/04/2017

Titles & IDs
Public title
Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial
Scientific title
First in Human Evaluation of the Drug-Coated Chocolate Balloon for Percutaneous Transluminal Revascularization of Infrainguinal Arterial Disease
Secondary ID [1] 0 0
CLP004
Universal Trial Number (UTN)
Trial acronym
ENDURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Vascular Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Paclitaxel Coated Chocolate Balloon Angioplasty

Experimental: Drug Coated Chocolate - Paclitaxel Coated Chocolate Balloon Angioplasty


Treatment: Devices: Paclitaxel Coated Chocolate Balloon Angioplasty
Balloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
3 Months (BTK) or 6 Months (ATK)
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
approx 1 hour
Secondary outcome [2] 0 0
Technical Success - This is defined as the percentage of cases in which the DCC is able to be delivered to and inflated at the intended target lesion location successfully.
Timepoint [2] 0 0
approx 1 hour
Secondary outcome [3] 0 0
Device Related Adverse Events (AEs) - Occurrence and Severity of any DCC Related AEs will be analyzed
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Freedom from Target Lesion Revascularization (TLR) - This will calculate the number of patients who do not require a clinically indicated TLR. Clinically indicated TLR is defined as any repeat percutaneous intervention at the DCC target lesion or bypass surgery at the DCC target vessel performed for >50% restenosis or another complication of the target lesion
Timepoint [4] 0 0
30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
Secondary outcome [5] 0 0
Amputation Free Survival - This is a composite endpoint which counts the number of patients who experience limb salvage. Patients will fail this endpoint if they undergo a major amputation (defined as unplanned amputation at or above the ankle) or if a procedure related death occurs.
Timepoint [5] 0 0
30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
Secondary outcome [6] 0 0
Patency - The percentage of cases in which the treated lesion is patent. Patency is demonstrated by a Peak Systolic Velocity ratio <2.5 at the target lesion assessed on Duplex Ultrasound without the need for re-intervention.
Timepoint [6] 0 0
6 Months / 12 Months (ATK only)

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Bad Krozingen
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
TriReme Medical, LLC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02129127
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, MD
Address 0 0
Auckland City Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications