Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Clearway™ Balloon vs. Mechanical Thrombectomy as Initial Treatment for Acute Limb Ischemia: A Randomized Controlled Trial

Conditions
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Critical Limb Ischemia

Intervention / Treatment
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* Device: Endovascular peripheral intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CLEARWAY GROUP<br>Endovascular peripheral intervention - Percutaneous transluminal angioplasty with simultaneous in situ thrombolysis (local thrombolytic plus low pressure balloon angioplasty) with Clearway balloon | Device: Endovascular peripheral intervention<br>* 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<br>* Other names: AngioJet Rheolytic Thrombectomy System;|
| Active Comparator: ANGIOJET GROUP<br>Endovascular peripheral intervention - Percutaneous transluminal angioplasty with simultaneous mechanical thrombectomy with AngioJet Rheolytic Thrombectomy System | Device: Endovascular peripheral intervention<br>* 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<br>* Other names: AngioJet Rheolytic Thrombectomy System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute or critical limb ischemia with angiographic thrombus