Clinical trial NCT02129127: Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial
Official title: First in Human Evaluation of the Drug-Coated Chocolate Balloon for Percutaneous Transluminal Revascularization of Infrainguinal Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Lead sponsor: TriReme Medical, LLC
Sponsor class: INDUSTRY
First posted: 2014-05-02
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Late Lumen Loss (LLL)
timeFrame: 3 Months (BTK) or 6 Months (ATK)
Secondary outcomes:
measure: Device Success
timeFrame: approx 1 hour
measure: Technical Success
timeFrame: approx 1 hour
measure: Device Related Adverse Events (AEs)
timeFrame: 30 days
measure: Freedom from Target Lesion Revascularization (TLR)
timeFrame: 30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
measure: Amputation Free Survival
timeFrame: 30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
measure: Patency
timeFrame: 6 Months / 12 Months (ATK only)
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Universitats Herzzentrum Bad Krozingen
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Auckland City Hospital
name: Andrew Holden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitats Herzzentrum Bad Krozingen
name: Thomas Zeller, MD
role: PRINCIPAL_INVESTIGATOR
References: