Excimer Laser Combined With DCB Compared With Angioplasty Alone in the Treatment of Infrapopliteal Lesions.
NCT ID: NCT04365075
Last Updated: 2022-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
184 participants
INTERVENTIONAL
2019-01-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Excimer Laser Combined with DCB
Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.
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.
Angioplasty Alone
Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
No
Sponsors
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Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Locations
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Yongquan Gu
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XuanwuH202001
Identifier Type: -
Identifier Source: org_study_id
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