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

Critical Limb Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04365075
• Other study ID #: XuanwuH202001
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2022
• Source: Xuanwu Hospital, Beijing
• Contact: jianming guo, M.D.
• Phone: 13146369562
• Email: guojianming[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Infrapopliteal Lesions
• Ischemia

Intervention

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

Locations

Country	Name	City	State
China	Yongquan Gu	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion revascularization rate	Free target vascular occlusion and clinically driven target lesion revascularization rate confirmed by ultrasound examination.	6-months
Secondary	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
Secondary	Major amputation rate	The rate of major amputation.	6-months
Secondary	Mortality	The ratio of deaths	6-months
Secondary	Ankle Brachial Index		6-months
Secondary	transcutaneous oxygen pressure		6-months
Secondary	Wound healing wagner score (for patients with Rutherford classification 5)	Wound healing wagner score (for patients with Rutherford classification 5).	6-months
Secondary	Length of hospital stay		6-months
Secondary	hospitalization costs		6-months