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

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ClinicalTrials.gov Identifier: NCT02129127
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : April 14, 2017
Sponsor:
Information provided by (Responsible Party):
TriReme Medical, LLC

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.

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Device: Paclitaxel Coated Chocolate Balloon Angioplasty Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First in Human Evaluation of the Drug-Coated Chocolate Balloon for Percutaneous Transluminal Revascularization of Infrainguinal Arterial Disease
Study Start Date : March 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Drug Coated Chocolate
Paclitaxel Coated Chocolate Balloon Angioplasty
Device: Paclitaxel Coated Chocolate Balloon Angioplasty
Balloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel




Primary Outcome Measures :
  1. Late Lumen Loss (LLL) [ Time Frame: 3 Months (BTK) or 6 Months (ATK) ]
    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 :
  1. Device Success [ Time Frame: approx 1 hour ]
    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.

  2. Technical Success [ Time Frame: approx 1 hour ]
    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.

  3. Device Related Adverse Events (AEs) [ Time Frame: 30 days ]
    Occurrence and Severity of any DCC Related AEs will be analyzed

  4. Freedom from Target Lesion Revascularization (TLR) [ Time Frame: 30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only) ]
    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

  5. Amputation Free Survival [ Time Frame: 30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only) ]
    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.

  6. Patency [ Time Frame: 6 Months / 12 Months (ATK only) ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129127


Locations
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Germany
Universitats Herzzentrum Bad Krozingen
Bad Krozingen, Germany
New Zealand
Auckland City Hospital
Auckland, New Zealand
Sponsors and Collaborators
TriReme Medical, LLC
Investigators
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Principal Investigator: Andrew Holden, MD Auckland City Hospital
Principal Investigator: Thomas Zeller, MD Universitats Herzzentrum Bad Krozingen

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Responsible Party: TriReme Medical, LLC
ClinicalTrials.gov Identifier: NCT02129127     History of Changes
Other Study ID Numbers: CLP004
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action