Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial (NCT02129127) | Clinical Trial Compass
CompletedNot Applicable
Drug-Coated Chocolate PTA Balloon in Patients With Peripheral Arterial Disease - The ENDURE Trial
Germany, New Zealand67 participantsStarted 2014-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.