Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions.

Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia.

This study was designed to compare excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.

Study Overview

• Status: Recruiting
• Conditions: Critical Limb Ischemia; Infrapopliteal Lesions
• Intervention / Treatment: Device: Excimer Laser Combined with DCB; Device: Angioplasty Alone

Detailed Description

This is a randomized study comparing excimer laser combined with drug-coated baloons with angioplasty alone in the treatment of infrapopliteal lesions in patients with critical limb ischemia.

• Study Type: Interventional
• Enrollment (Anticipated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianming Guo, M.D.; Phone Number: 13146369562; Email: guojianming@aliyun.com
• Study Contact Backup: Name: yongquan gu, M.D.; Phone Number: 15901598209; Email: gu15901598209@aliyun.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Yongquan Gu
      • Contact: Jianming Guo, M.D.; Phone Number: 13146369562; Email: guojianming@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The treatment vessel is DeNovo
• Stenotic (>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s)
• Reference target vessel diameter between 2-4.0 mm by visual assessment
• Documented Rutherford Class 4 or 5 symptomatic critical limb ischemia
• The patient must be >18 years of age
• Life-expectancy of more than 12 months
• The patient has no child bearing potential or negative serum pregnancy test
• within 7 days of the index procedure
• The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
• The patient must provide written patient informed consent that is approved by the ethics committee

Anatomic Inclusion Criteria:

• All inflow lesions successfully (<30 residual stenosis) treated prior to target lesion treatment during same procedure or according standard of care without unresolved complications
• At least one angiographically visible target at the ankle for establishment of straight line flow.

Exclusion Criteria:

• Patient refusing treatment
• The target vessel segment diameter is not suitable for available catheter design.
• Unsuccessfully treated endovascular or bypass( >30% residual stenosis) proximal ( iliac, superficial femoral, popliteal) inflow limiting arterial/graft stenosis
• Lesion lies within or adjacent to an aneurysm
• The patient has a known allergy to heparin, Aspirin or other antiaggregant therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
• The patient has a history of prior life-threatening contrast media reaction.
• The patient is currently enrolled in another investigational device or drug trial.
• The patient is currently breast-feeding, pregnant or intends to become pregnant.
• The patient is unable to provide informed consent
• The patient has end stage renal disease (currently on any form of dialysis)
• Known Left Ventricular Ejection Fraction < 35%
• The patient has had a myocardial ischemia within 30 days prior to enrollment
• The patient has had a cardiovascular accident within 90 days prior to enrollment
• Serum Creatinine > 150 µmol
• The patient has a previous bypass in the target limb
• The patient has a current systemic infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Excimer Laser Combined with DCB; Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.	Device: Excimer Laser Combined with DCB; Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.
Active Comparator: Angioplasty Alone; Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.	Device: Angioplasty Alone; Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion revascularization rate	Free target vascular occlusion and clinically driven target lesion revascularization rate confirmed by ultrasound examination.	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse events	Incidence of major adverse events (including operative-related arterial dissection, perforation, rupture, embolization, acute thrombosis, pseudoaneurysm, and hematoma formation).	6-months
Major amputation rate	The rate of major amputation.	6-months
Mortality	The ratio of deaths	6-months
Ankle Brachial Index		6-months
transcutaneous oxygen pressure		6-months
Wound healing wagner score (for patients with Rutherford classification 5)	Wound healing wagner score (for patients with Rutherford classification 5).	6-months
Length of hospital stay		6-months
hospitalization costs		6-months

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 9, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Angioplasty; Excimer Laser; drug-coated baloons
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: XuanwuH202001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No