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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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Scientific title
First in Human Evaluation of the Drug-Coated Chocolate Balloon for Percutaneous Transluminal Revascularization of Infrainguinal Arterial Disease
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Secondary ID [1]
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CLP004
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Universal Trial Number (UTN)
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Trial acronym
ENDURE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peripheral Vascular Disease
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Late Lumen Loss (LLL)
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Assessment method [1]
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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.
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Timepoint [1]
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3 Months (BTK) or 6 Months (ATK)
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Secondary outcome [1]
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Device Success
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Assessment method [1]
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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.
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Timepoint [1]
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approx 1 hour
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Secondary outcome [2]
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Technical Success
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Assessment method [2]
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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.
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Timepoint [2]
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approx 1 hour
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Secondary outcome [3]
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Device Related Adverse Events (AEs)
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Assessment method [3]
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Occurrence and Severity of any DCC Related AEs will be analyzed
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Timepoint [3]
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30 days
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Secondary outcome [4]
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Freedom from Target Lesion Revascularization (TLR)
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Assessment method [4]
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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
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Timepoint [4]
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30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
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Secondary outcome [5]
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Amputation Free Survival
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Assessment method [5]
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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.
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Timepoint [5]
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30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
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Secondary outcome [6]
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Patency
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Assessment method [6]
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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.
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Timepoint [6]
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6 Months / 12 Months (ATK only)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2017
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Sample size
Target
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Accrual to date
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Final
67
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Bad Krozingen
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Country [2]
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New Zealand
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State/province [2]
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Auckland
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
TriReme Medical, LLC
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT02129127
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Andrew Holden, MD
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Address
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Auckland City Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02129127
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