- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02129127
Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial (ENDURE)
First in Human Evaluation of the Drug-Coated Chocolate Balloon for Percutaneous Transluminal Revascularization of Infrainguinal Arterial Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bad Krozingen, Germany
- Universitats Herzzentrum Bad Krozingen
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Auckland, New Zealand
- Auckland City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Drug Coated Chocolate
Paclitaxel Coated Chocolate Balloon Angioplasty
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Balloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Late Lumen Loss (LLL)
Time Frame: 3 Months (BTK) or 6 Months (ATK)
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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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3 Months (BTK) or 6 Months (ATK)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device Success
Time Frame: approx 1 hour
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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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approx 1 hour
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Technical Success
Time Frame: approx 1 hour
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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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approx 1 hour
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Device Related Adverse Events (AEs)
Time Frame: 30 days
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Occurrence and Severity of any DCC Related AEs will be analyzed
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30 days
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Freedom from Target Lesion Revascularization (TLR)
Time Frame: 30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
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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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30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
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Amputation Free Survival
Time Frame: 30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
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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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30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
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Patency
Time Frame: 6 Months / 12 Months (ATK only)
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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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6 Months / 12 Months (ATK only)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Holden, MD, Auckland City Hospital
- Principal Investigator: Thomas Zeller, MD, Universitats Herzzentrum Bad Krozingen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Vascular Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- CLP004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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