Back to resultsDrug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial (ENDURE)
Primary Purpose
Peripheral Vascular Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Paclitaxel Coated Chocolate Balloon Angioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Vascular Disease
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.
Sites / Locations
- Universitats Herzzentrum Bad Krozingen
- Auckland City Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug Coated Chocolate
Arm Description
Paclitaxel Coated Chocolate Balloon Angioplasty
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Device Related Adverse Events (AEs)
Occurrence and Severity of any DCC Related AEs will be analyzed
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02129127
Brief Title
Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial
Acronym
ENDURE
Official Title
First in Human Evaluation of the Drug-Coated Chocolate Balloon for Percutaneous Transluminal Revascularization of Infrainguinal Arterial Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriReme Medical, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Vascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Drug Coated Chocolate
Arm Type
Experimental
Arm Description
Paclitaxel Coated Chocolate Balloon Angioplasty
Intervention Type
Device
Intervention Name(s)
Paclitaxel Coated Chocolate Balloon Angioplasty
Intervention Description
Balloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel
Primary Outcome Measure Information:
Title
Late Lumen Loss (LLL)
Description
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.
Time Frame
3 Months (BTK) or 6 Months (ATK)
Secondary Outcome Measure Information:
Title
Device Success
Description
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.
Time Frame
approx 1 hour
Title
Technical Success
Description
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.
Time Frame
approx 1 hour
Title
Device Related Adverse Events (AEs)
Description
Occurrence and Severity of any DCC Related AEs will be analyzed
Time Frame
30 days
Title
Freedom from Target Lesion Revascularization (TLR)
Description
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
Time Frame
30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
Title
Amputation Free Survival
Description
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.
Time Frame
30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
Title
Patency
Description
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.
Time Frame
6 Months / 12 Months (ATK only)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Holden, MD
Organizational Affiliation
Auckland City Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Zeller, MD
Organizational Affiliation
Universitats Herzzentrum Bad Krozingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitats Herzzentrum Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
12. IPD Sharing Statement
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Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial
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