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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Balloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel
Universitats Herzzentrum Bad Krozingen
Bad Krozingen, Germany
Auckland City Hospital
Auckland, New Zealand
Late Lumen Loss (LLL)
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.
Time frame: 3 Months (BTK) or 6 Months (ATK)
Device Success
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.
Time frame: approx 1 hour
Technical Success
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.
Time frame: approx 1 hour
Device Related Adverse Events (AEs)
Occurrence and Severity of any DCC Related AEs will be analyzed
Time frame: 30 days
Freedom from Target Lesion Revascularization (TLR)
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
Time frame: 30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
Amputation Free Survival
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 30 days / 3 Months (BTK only) / 6 Months / 12 Months (ATK only)
Patency
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.
Time frame: 6 Months / 12 Months (ATK only)