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

Not Applicable

Recruiting

• Conditions: Critical Limb Ischemia; Infrapopliteal Lesions
• Interventions: Device: Excimer Laser Combined with DCB; Device: Angioplasty Alone

• Registration Number: NCT04365075
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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.

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 Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-09
• Last Update Posted: 2022-10-12
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Excimer Laser Combined with DCB	Excimer Laser Combined with DCB	Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.
Angioplasty Alone	Angioplasty Alone	Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.

Primary Outcome Measures

Name	Time	Method
Target lesion revascularization rate	6-months	Free target vascular occlusion and clinically driven target lesion revascularization rate confirmed by ultrasound examination.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yongquan Gu; 🇨🇳 Beijing, Beijing, China