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

NCT ID: NCT02129127

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-04-30

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.

Conditions

Peripheral Vascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug Coated Chocolate

Paclitaxel Coated Chocolate Balloon Angioplasty

Group Type: EXPERIMENTAL

Paclitaxel Coated Chocolate Balloon Angioplasty

Intervention Type: DEVICE

Balloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel

Interventions

Paclitaxel Coated Chocolate Balloon Angioplasty

Balloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel

Intervention Type: DEVICE

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TriReme Medical, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Holden, MD

Role: PRINCIPAL_INVESTIGATOR

Auckland City Hospital

Thomas Zeller, MD

Role: PRINCIPAL_INVESTIGATOR

Universitats Herzzentrum Bad Krozingen

Locations

Universitats Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

Auckland City Hospital

Auckland, , New Zealand

Countries

Germany; New Zealand

Other Identifiers

CLP004

Identifier Type: -

Identifier Source: org_study_id