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

NCT00869375 | Terminated Results DMC

• 1 other identifier: CLEARWAY-CLI
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Limb Ischemia

Keywords

acute or critical limb ischemia with angiographic thrombus

Outcome Measures

Primary Outcomes (2)

• Immediate Distal Embolization Detected by Angiographic and/or Clinical Evidence

  24 hours after the procedure

• Incidence of Bleeding Complications

  24 hours after the procedure

Study Arms (2)

CLEARWAY GROUP

ACTIVE COMPARATOR

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

ANGIOJET GROUP

ACTIVE COMPARATOR

Endovascular peripheral intervention - Percutaneous transluminal angioplasty with simultaneous mechanical thrombectomy with AngioJet Rheolytic Thrombectomy System

Device: Endovascular peripheral intervention

Interventions

Endovascular peripheral intervention DEVICE

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

Also known as: Clearway Balloon, AngioJet Rheolytic Thrombectomy System

ANGIOJET GROUP; CLEARWAY GROUP

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oklahoma: lead
• Atrium Medical Corporation: collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Limitations and Caveats

The main limitation of this trial was slow enrollment. This led to early termination leading to small numbers of subjects analyzed. This makes the results uninterpretable.

Results Point of Contact

• Title: J. Emilio Exaire MD
• Organization: OUHSC

jose-exaire@ouhsc.edu

405 271 4742

Study Officials

• J. Emilio Exaire, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 21, 2014
• Results First Posted: July 21, 2014

Record last verified: 2014-06

Locations

US (1)