Viewing Study NCT03884257



Ignite Creation Date: 2024-05-06 @ 12:55 PM
Last Modification Date: 2024-10-26 @ 1:06 PM
Study NCT ID: NCT03884257
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-05-09
First Post: 2019-03-11

Brief Title: A Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of the Femoropopliteal Artery Compared to the Medtronic INPACT Admiral Drug-coated Balloon
Sponsor: ID3 Medical
Organization: ID3 Medical

Study Overview

Official Title: A Randomized Controlled Non-inferiority Trial to Evaluate the Safety and Efficacy of the Passeo-18 Lux Drug-coated Balloon of Biotronik in the Treatment of Subjects with Stenotic Restenotic or Occlusive Lesions of the Femoropopliteal Artery Compared to the Medtronic INPACT Admiral Drug-coated Balloon
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BIOPACT-RCT
Brief Summary: The BIOPACT RCT tiral investigates the efficacy and safety of stenosis restenosis or occlusions in the femoropopliteal artery of patients presenting a rutherford classification 23 or 4 with a Passeo-18 Lux drug-coated balloon of Biotronik The Paclitaxel eluting balloons are designed for percutaneous transluminal angioplasties in which the balloon will dilate the artery upon inflation and deliver the paclitaxel locally

An expected total of 151 patients will be treated with the Passeo-18 Lux and compared to a control group of another 151 patients that will be treated with the INPACT Admiral drug-coated balloon of Medtronic Assignment to the treatment groups will be at random The study will be conducted in two phases A first pilot study phase of 120 patients distributed evenly over both treatment groups and a second phase to formally test the non-inferiority hypothesis

The balloon is coated with Paclitaxel intended to avoid cellular proliferation The drug is released by means of rapid inflation as to release a high dose in a short amount of time Patients will be invited for a follow-up visit at 1 6 and 12 months post-procedure

The primary efficacy endpoints are defined as follows Freedom from clinically-driven target lesion revascularization at 12 months Freedom from device- and procedure-related death through 30 days post-index procedure major target limb amputation through 12 months post-procedure and clinically-driven target vessel revascularization through 12 months post-index procedure The secondary endpoints are defined as acute device success acute procedural success freedom from all cause of death major target limb amputation and clinically driven target vessel revascularisation through 30 days post-procedure sustained clinical improvement no major adverse events through 6 and 12 months post-procedure primary patency target lesion revascularisation target vessel revascularisation binary restenosis major target limb amputation thrombosis at target lesion change of walking impairment questionnaire score from baseline change in target limb rutherford classification or ABI
Detailed Description: The objective of this clinical investigation is to assess the safety and efficacy of the Passeo-18 Lux DCB for the treatment of stenotic restenotic or occlusive lesions of the femoropopliteal arteries Furthermore a non-inferiority hypothesis will be tested with the INPACT Admiral DCB as comparator

The patients will be selected based on the investigators assessment evaluation of the underlying disease and the eligibility criteria The patients medical condition should be stable with no underlying medical condition which would prevent them from performing the required testing or from completing the study Patients should be geographically stable willing and able to cooperate in this clinical study and remain available for long term follow-up The patient is considered enrolled in the study after obtaining the patients informed consent if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion

Prior to the index procedure the following will be collected an informed consent for data collection demographics medical history medication record physical examination clinical category of acute limb ischemia Rutherford category the resting ankle-brachial index ABI blood sample test complete blood count comprehensive metabolic panel and if applicable pregnancy test and a walking impairment questionnaire

During the procedure the guidewire will cross the entire study lesion after which the lesion will be assessed through angiography A pre-dilatation with a standard non-drug-coated balloon will be performed followed by a dilatation of the lesion with either a Passeo-18 Lux Biotronik or an INPACT Admiral balloon Medtronic If dilatation was not successful 30 stenosis perforation occlusive or flow limiting dissection prolonged inflation should be attempted after which bail-out stenting with a bare nitinol stent is allowed in case of inadequate results

The regular follow-up is necessary to monitor the condition of the patient and the results of the procedure The patients will be invited for the following required follow-up visits at 16 and 12 months During these visit the following data will be collected medication record physical exam target limb ABI and Rutherford classification duplex ultrasound of target vessel walking impairment questionnaire and possible adverse events

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None