Evaluation of the Safety and Efficacy of the Long (> 150mm) Passeo-18 Lux Drug-coated Balloon of Teleflex in the Treatment of Subjects With Stenotic, Restenotic or Occlusive Lesions of the Femoropopliteal Artery

N/ANot Yet RecruitingNCT07385573

KANDO Research200 enrolled

Overview

This clinical trial will evaluate the study device, Passeo®-18 Lux® paclitaxel-releasing percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of new or recurring cholesterol-related blockages in the arteries of the lower leg. The device that is used in this trial has been assessed in several previous studies for safety and effectiveness. The device is already approved for use in Europe. It has a "CE mark," which means it meets the European Union's safety, health and performance standards. This trial is being done to gather additional information on how well the device works and how safe it is when used in everyday medical care with specific attention to the longer lengths of the balloon, as it comes in different sizes.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Drug Coated Balloon Peripheral Arterial Disease

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Lesion(s) in the infrainguinal arteries 2. Reference Vessel Diameter 2-7mm 3. De novo stenotic, restenotic post POBA (the phenomenon where atherosclerotic plaques form in the treated arteries after balloon angioplasty), or occlusive lesion(s) 4. Target lesion must have angiographic evidence of ≥70% stenosis 5. Lesion length ≥ 3cm 6. Successful crossing of the target lesion with the guide wire 7. Successful predilatation, defined as residual stenosis \<50% without flow limiting dissection grade D, E or F (Modified Fujihara classification) 8. Rutherford Class 2-5 9. Study participant is able to provide consent and has signed and dated the informed consent form Exclusion Criteria: 1. Life expectancy ≤ 1 year 2. Study participant is currently participating in another investigational drug or device study that has not reached its primary endpoint yet. 3. Study participant is pregnant or planning to become pregnant during the course of the study. 4. Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion). 5. Prior bypass surgery of target vessel 6. In-stent restenosis 7. Planned major amputation of the target limb 8. Thrombus in the target vessel 9. Known allergy to contrast media that cannot be adequately controlled with premedication

Outcomes

Primary Outcomes

Freedom from Clinically Driven Target Lesion Revascularization (TLR) (Primary Clinical Performance Endpoint)

The primary clinical performance endpoint is freedom from clinically driven target lesion revascularization (TLR) within 12 months post-index procedure.

Time frame: 12-months post-index procedure

Freedom from Major Adverse Events (MAE) through 12 months

The primary safety endpoint is freedom from major adverse events (MAE), defined as a composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and clinically driven TLR, within 12 months post-index procedure.

Time frame: Through 12 months post-index procedure

Secondary Outcomes

Successful delivery, inflation, deflation, and retrieval of the intact study device during index procedure.

Device success is defined as successful delivery, balloon inflation, deflation, and retrieval of the intact study device without burst below rated burst pressure.

Time frame: During index procedure

Restoration of target lesion with ≤30% residual stenosis in final angiogram.

Procedural success is defined as restoration of the target lesion with ≤30% residual stenosis in the final angiogram.

Time frame: After index procedure

Number of deaths from any cause (all-cause mortality) at 1, 6, 12, 24, 36, 48, and 60 months

All-cause mortality is defined as the total number of deaths from any cause among study participants at each scheduled follow-up time point.