Critical Limb Ischemia, Infrapopliteal Lesions
Conditions
Keywords
Excimer Laser, Angioplasty, drug-coated baloons
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.
Interventions
DEVICEExcimer Laser Combined with DCB
Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.
DEVICEAngioplasty Alone
Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion revascularization rate | 6-months | Free target vascular occlusion and clinically driven target lesion revascularization rate confirmed by ultrasound examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major amputation rate | 6-months | The rate of major amputation. |
| Mortality | 6-months | The ratio of deaths |
| Ankle Brachial Index | 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). |
| Wound healing wagner score (for patients with Rutherford classification 5) | 6-months | Wound healing wagner score (for patients with Rutherford classification 5). |
| Length of hospital stay | 6-months | — |
| hospitalization costs | 6-months | — |
| transcutaneous oxygen pressure | 6-months | — |
Countries
China
Contacts
Primary Contactjianming guo, M.D.
Backup Contactyongquan gu, M.D.
Outcome results
None listed