Critical Limb Ischemia
Conditions
Keywords
acute or critical limb ischemia with angiographic thrombus
Brief summary
The purpose of this study is to compare the effects (positive and negative) of two different devices available to treat people with critical limb ischemia, which involves a sudden decrease in blood flow to the leg that causes a potential threat to the limb and causes pain at rest, ulcers or gangrene. One device is the Clearway balloon, which delivers a drug to dissolve the clot where the blockage is. The other device is the Angiojet, which removes the clot in a mechanical way (vacuum effect). This research is being done because currently there is no single proven effective treatment for this condition. Even though, both these devices are commonly used in the clinical practice to treat critical limb ischemia, there are no studies that compare these devices and help us see which one may be better for these patients.
Detailed description
This prospective randomized clinical trial in patients with peripheral vascular disease and acute or subacute arterial thrombosis will compare percutaneous transluminal angioplasty and simultaneous in situ thrombolysis using the Clearway balloon system with mechanical thrombectomy with the Angiojet system. Main endpoints are the time to successful revascularization, the frequency of distal embolization and the incidence of bleeding complications.
Interventions
DEVICEEndovascular peripheral intervention
Clearway Balloon: percutaneous transluminal angioplasty with simultaneous in situ thrombolysis using the Clearway balloon AngioJet Rheolytic Thrombectomy System: percutaneous transluminal angioplasty with simultaneous mechanical thrombectomy using the Angiojet
Sponsors
Atrium Medical Corporation
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults between 18 and 85 years of age * Diagnosis of acute limb ischemia (defined as an abrupt onset of lower extremity pain with loss of peripheral pulses and absent Doppler pulses in at least one artery and/or ultrasonographic evidence of decreased or absent blood flow to the affected limb) or Diagnosis of critical limb ischemia (defined as resting lower extremity pain with an ABI of \<0.4 and/or ultrasonographic evidence of decreased or absent blood flow to the affected limb). * Angiographic confirmation of thrombus. * Need of an intervention within 21 days of the onset of symptoms
Exclusion criteria
* Any contraindication for thrombolytic therapy ABSOLUTE CONTRAINDICATIONS: A. Any history of intracranial hemorrhage; recent (within three months) hemorrhagic cerebrovascular accident (CVA) / transient ischemic attack (TIA) or significant closed head or facial injury. B. Known intracranial neoplasm or arteriovenous malformation. C. Suspected aortic dissection. D. Active bleeding diathesis or hemostatic defects: (Excluding menses); active internal RELATIVE CONTRAINDICATIONS: Fibrinolytic therapy may be used with the presence of these conditions upon clinical assessment or treatment dependent upon bleeding risks: A. History of chronic, severe, and poorly controlled blood pressure or Severe uncontrolled hypertension on presentation (SBP \>180, DBP \>110). B. History of prior ischemic stroke (greater than 3 months) dementia, or known intracranial pathology not covered in absolute contraindications. C. Traumatic or prolonged CPR (\> 10 minutes), major surgery (\< 3 weeks), or recent trauma, including head trauma (2-4 weeks). D. Recent (within 2 to 4 weeks) internal bleeding. E. Noncompressible vascular punctures. F. Pregnancy or recent obstetrical delivery. G. Active peptic ulcer disease. H. Anticoagulant use (INR \> 2-3)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence | 24 hours after the procedure |
| Incidence of Bleeding Complications | 24 hours after the procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CLEARWAY GROUP 3 patients were randomized in this group. | 3 |
| ANGIOJET GROUP 3 patients were randomized in this group | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | CLEARWAY GROUP | ANGIOJET GROUP | Total |
|---|---|---|---|
| Age, Continuous | 45 years | 63 years | 54 years |
| Current smokers | 3 participants | 1 participants | 4 participants |
| Diabetes | 2 participants | 1 participants | 3 participants |
| Dyslipidemia | 2 participants | 1 participants | 3 participants |
| Hypertension | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 1 / 3 | 0 / 3 |
Outcome results
Primary
Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence
Time frame: 24 hours after the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CLEARWAY GROUP | Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence | 0 participants |
| ANGIOJET GROUP | Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence | 0 participants |
Primary
Incidence of Bleeding Complications
Time frame: 24 hours after the procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CLEARWAY GROUP | Incidence of Bleeding Complications | 0 participants |
| ANGIOJET GROUP | Incidence of Bleeding Complications | 0 participants |