A Single Arm Trial to Evaluate the Safety and Efficacy of the Long (> 150mm) PasseoTM-18 LuxTM Drug-coated Balloon in the Treatment of Subjects With Infrainguinal Stenotic, Restenotic or Occlusive Lesions

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 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria * Study participant is ≥ 18 years and ≤ 99 years old * Lesion(s) in the infrainguinal arteries: * Lesion above the knee (ATK): Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau) * Lesion below the knee (BTK): Target lesions involve arteries below the tibial plateau * RVD 2-7mm * De novo stenotic, restenotic post POBA, or occlusive lesion(s) * Target lesion must have angiographic evidence of ≥70% stenosis * Lesion length ≥ 3cm * Successful crossing of the target lesion with the guide wire * Successful predilatation, defined as residual stenosis \<50% Rutherford Class 2-5 * Study participant is able to provide consent and has signed and dated the informed consent form Exclusion criteria * Life expectancy ≤ 1 year * Study participant is currently participating in another investigational drug or device study that has not reached its primary endpoint yet. * Study participant is pregnant, planning to become pregnant, or father children during the course of the study. * Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion). * Prior bypass surgery of target vessel * Planned major amputation of the target limb * Thrombus in the target vessel * Known allergy to contrast media that cannot be adequately controlled with premedication * Study participant has a single target lesion that involves both ATK and BTK segments

Outcomes

Primary Outcomes

Freedom from clinically-driven target lesion revascularization (fcd-TLR) within 12 months post-index procedure.

The primary clinical performance endpoint is Freedom from clinically-driven target lesion revascularization (fcd-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- or 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.

Time frame: At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months

Primary patency of target lesion (freedom from clinically driven target lesion revascularization [fcd-TLR] and binary restenosis)

Primary patency is defined as a composite of freedom from clinically driven target lesion revascularization (fcd-TLR) and binary restenosis, where restenosis is defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4 or ≥50% stenosis as assessed by an independent DUS core lab.

Time frame: At scheduled follow-up visits: 1, 6, 12, and 24 months

Freedom from Clinically-driven Target Lesion Revascularization (fcd-TLR)

Clinically driven target lesion revascularization (fcd-TLR) is defined as any reintervention performed for ≥50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms.

Time frame: At scheduled follow-up visits: 1, 6, 24, 36, 48, and 60 months

Freedom from Clinically-driven Target Vessel Revascularization (TVR)

Clinically driven TLR is defined as any reintervention performed for ≥50% diameter stenosis (visual estimate) at the target lesion after documentation of recurrent clinical symptoms of the patient.

Time frame: At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months

Freedom from major adverse events (MAE: device- or procedure-related mortality, major target limb amputation, and clinically driven TLR)

Major adverse events (MAE) are defined as a composite of freedom from device- or procedure-related mortality through 30 days, freedom from major target limb amputation, and freedom from clinically driven target lesion revascularization (TLR).

Time frame: At scheduled follow-up visits: 1, 6, 24, 36, 48, and 60 months

Amputation-free survival (AFS: alive without major amputation)

Amputation-free survival (AFS) is defined as being alive without major amputation.

Time frame: At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months

Freedom from Major Target Limb Amputation

Major target limb amputation is defined as any amputation above the ankle in the target limb.

Time frame: At scheduled follow-up visits: 1, 6, 12, 24, 36, 48, and 60 months

Change from baseline in Rutherford classification at 1, 6, 12, and 24 months

Change from baseline in Rutherford classification will be assessed to evaluate the severity of ischemia in the lower extremities among study participants.

Time frame: At scheduled follow-up visits: 1, 6, 12, and 24 months

Change from baseline in EQ-5D quality of life score at 1, 12, and 24 months

Change from baseline in health-related quality of life, as assessed by the EQ-5D questionnaire, will be evaluated among study participants.

Time frame: At scheduled follow-up visits: 1, 12, and 24 months

Change from baseline in Walking Impairment Questionnaire (WIQ) score at 1, 12, and 24 months

Change from baseline in functional limitations, as assessed by the Walking Impairment Questionnaire (WIQ), will be evaluated among study participants with peripheral artery disease (PAD).

Time frame: At scheduled follow-up visits: 1, 12, and 24 months

Change from baseline in ABI at 1, 6, 12, and 24 months

ABI is defined as Ankle-Brachial Index (ABI) measurement of the limb being treated

Time frame: at 1, 6, 12, and 24 months

A Single Arm Trial to Evaluate the Safety and Efficacy of the Long (> 150mm) PasseoTM-18 LuxTM Drug-coated Balloon in the Treatment of Subjects With Infrainguinal Stenotic, Restenotic or Occlusive Lesions

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts