Post-market Registry to Assess the Clinical Performance and Safety of the Passeo-18 Lux in Infrainguinal Arteries

NCT05175703 | Unknown

• 1 other identifier: AJIRB-DEV-DE4-17-478
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of his study is to collect short term and long term clinical evaluation data of the Passeo-18 Lux Paclitaxel releasing balloon catheter, subject to patients who visit hospital from arteriosclerosis in the infrainguinal arteries in actual clinical environment. Research institute for enrollment, and period; It is planned to enroll about 200 subjects in 9 domestic research institutes. It is expected to require about 12-18 months to enroll the subjects. Subject follow-up schedule; Perform follow-up by phone call or clinical assessment at 1, 6, 12, and 24 months of the postoperative time point

Conditions

Angioplasty, Balloon; Disease, Peripheral Artery

Outcome Measures

Primary Outcomes (3)

• Clinical primary endpoints

  No occurrence of Major Adverse Event (MAE); No death or lower limb amputation in the subject from the index procedure for 30 days

  30 days

• Clinical primary endpoints

  No occurrence of Major Adverse Event (MAE); No target vessel revascularization (TVR) within 6 months from index procedure.

  6 months

• Functional primary endpoints

  No target lesion revascularization (TLR) (a case showing at least 50% stenosis in visual inspection of target vessel in the patient with any recurred symptom) is needed clinically for 12 months after operation.

  12 months

Secondary Outcomes (6)

• TLR (Target Lesion Revascularzation) rate

  6-24 months

• TVR rate

  6-24 months

• Survival without amputation

  6-24 months

• device success

  during index procedure

• Technical success

  during index procedure

Study Arms (1)

the infrainguinal arteries disease group

OTHER

Actual patient group with any atherosclerotic change in the infrainguinal arteries

Device: Passeo-18 Lux Paclitaxel releasing Balloon Catheter

Interventions

Passeo-18 Lux Paclitaxel releasing Balloon Catheter DEVICE

collect short term and long term clinical evaluation data of the Passeo-18 Lux Paclitaxel releasing balloon catheter, subject to patients who visit hospital from arteriosclerosis in the infrainguinal arteries in actual clinical environment.

the infrainguinal arteries disease group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Person over 19 years old who is recognized as an adult in the civil law
• Person willing to sign a subject written consent
• Patient having infrainguinal arterial lesion that is adequate to intravascular treatment using Passeo-18 Lux Paclitaxel releasing Balloon Catheter
• Peripheral arterial disease in 2-5 grade of Rutherford
• Patient without at least one of significant lesions (≥50% of stenosis) in distal leaking artery. When there is at least one of opening blood vessels under the knee in treatment of arterial popliteal or at least one of opening cural vessel under the ankle in arterial treatment under the knee. Treatment of inflow arterial disease is allowed before the relevant treatment.)

You may not qualify if:

• Life expectancy ≤ 1 year
• Patient who is currently under medication of an investigation drug or treatment by a device that did not reach the primary endpoints.
• Subject during pregnancy or having a plan of pregnancy during the study period
• A guide wire could not passed into the target lesion (Successful passage of guide wire means its movement into the distal part of target lesion without causing arterial dissection or perforation by the end of guidewire.)
• Acute thrombosis is accompanied
• Major amputation is planned There is medical history of bypass surgery on target vessel

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Hospital

Suwon, Kyunggi, 16499, South Korea

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Je Hwan Won, MD

  Korean Society of Interventional Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The Passeo-18 Lux DCB

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: January 4, 2022
• Study Start: March 5, 2018
• Primary Completion: August 31, 2021
• Study Completion: January 31, 2022
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)