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

Capital Medical University

Status: Enrolling

Conditions: Critical Limb Ischemia; Infrapopliteal Lesions

Treatments: Device: Angioplasty Alone; Device: Excimer Laser Combined with DCB

Study type: Interventional

Funder types: Other

Identifiers

NCT04365075

XuanwuH202001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 2 patient groups

Excimer Laser Combined with DCB

Experimental group

Description:

Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.

Treatment:

Device: Excimer Laser Combined with DCB

Angioplasty Alone

Active Comparator group

Description:

Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.

Treatment:

Device: Angioplasty Alone