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

TriReme Medical

Status

Completed

Conditions

Peripheral Vascular Disease

Treatments

Device: Paclitaxel Coated Chocolate Balloon Angioplasty

Study type

Interventional

Funder types

Industry

Identifiers

NCT02129127

CLP004

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.