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Clinical Trials/EUCTR2014-003469-10-NL
EUCTR2014-003469-10-NL
Active, Not Recruiting
Phase 1

The application of contrast-enhanced ultrasound to facilitate thrombolysis in patients with acute peripheral arterial occlusions. - MUST Trial

VU University Medical Center0 sites20 target enrollmentJuly 9, 2015

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
VU University Medical Center
Enrollment
20
Status
Active, Not Recruiting
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 9, 2015
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
VU University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Men and women older than 18 years and younger than 85 years old
  • Patients with a maximum of 7 weeks complaints due to lower limb ischemia due to
  • thrombosed/occluded iliofemoral, femoropopliteal or femorocrural native arteries or femoropopliteal or
  • femorocrural venous or prosthetic bypass grafts
  • Anatomic suitability duplex ultrasound in case of iliac occlusion
  • Patients fit for thrombolysis i.e. with acute lower limb ischemia class I and IIa according to the
  • Rutherford classification (see attachment II)
  • Patients understand the nature of the procedure and provide written informed consent before enrolment
  • in the study
  • Are the trial subjects under 18? no

Exclusion Criteria

  • Patients with clinical complaints of acute lower limb ischemia due to thrombosis of the iliofemoral, femoropopliteal or femorocrural native arteries, or femoropopliteal or femorocrural venous or prosthetic bypass grafts more than 7 weeks
  • Patients with iliac occlusions anatomically not suitable for duplex ultrasound
  • Patients with thrombosed popliteal aneurysms
  • Patients with contra\-indications for the administration of antiplatelet therapy, anticoagulants or thrombolytics
  • Recent (less than 6 weeks) ischemic stroke, cerebral bleeding or myocardial infarction
  • Patients with recent (less than 6 weeks) surgery
  • Severe hypertension (diastolic blood pressure greater than 110 mm Hg, systolic blood pressure higher than 200 mm Hg)
  • Current malignancy or severe comorbid condition with a life expectancy of less than 6 months
  • Patients with uncorrected bleeding disorders (gastrointestinal ulcer, menorrhagia, liver failure)
  • Women with child\-bearing potential not taking adequate contraceptives or currently breastfeeding

Outcomes

Primary Outcomes

Not specified

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