Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial (ENDURE)
|ClinicalTrials.gov Identifier: NCT02129127|
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : April 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Vascular Disease||Device: Paclitaxel Coated Chocolate Balloon Angioplasty||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- Device Related Adverse Events (AEs) [ Time Frame: 30 days ]Occurrence and Severity of any DCC Related AEs will be analyzed
- 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
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129127
|Universitats Herzzentrum Bad Krozingen|
|Bad Krozingen, Germany|
|Auckland City Hospital|
|Auckland, New Zealand|
|Principal Investigator:||Andrew Holden, MD||Auckland City Hospital|
|Principal Investigator:||Thomas Zeller, MD||Universitats Herzzentrum Bad Krozingen|