Clinical trial NCT04365075: Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions.
Official title: Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Limb Ischemia
Infrapopliteal Lesions
Keywords: Excimer Laser
Angioplasty
drug-coated baloons
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Target lesion revascularization rate
timeFrame: 6-months
Secondary outcomes:
measure: Incidence of major adverse events
timeFrame: 6-months
measure: Major amputation rate
timeFrame: 6-months
measure: Mortality
timeFrame: 6-months
measure: Ankle Brachial Index
timeFrame: 6-months
measure: transcutaneous oxygen pressure
timeFrame: 6-months
measure: Wound healing wagner score (for patients with Rutherford classification 5)
timeFrame: 6-months
measure: Length of hospital stay
timeFrame: 6-months
measure: hospitalization costs
timeFrame: 6-months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yongquan Gu
state: Beijing
Study officials:
References: