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

Phase 2

Completed

• Conditions: thrombosis; Vascular occlusion; 10014523

• Registration Number: NL-OMON46851
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

* Men and women older than 18 years and younger than 85 years old
* Patients with a maximum of 2 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

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 2 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
* Pregnancy
* Patients who are currently participating in another investigational drug or device study
* Patients younger than 18 years or older than 85 years
* Patients with contra-indications for Luminity microbubbles i.e.
* Hypersensitivity to perflutren or other components of Luminity
* Recent acute coronary syndrome or clinically unstable ischemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders
* Patients known to have right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure >90 mmHg), uncontrolled systemic hypertension, and in patients with GOLD Stage IV COPD, diffuse interstitial fibrosis or adult respiratory distress syndrome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main endpoints will be the duration of thrombolysis needed for uninterrupted<br /><br>flow in the thrombosed native artery or bypass graft with outflow through at<br /><br>least 1 crural artery and microcirculation of the lower limb as measured by<br /><br>Laser Doppler Flowmetry on the skin of the lower limb. Furthermore, Severe<br /><br>Adverse Events (haemorrhagic complications, allergic reactions, in hospital<br /><br>mortality directly related to the treatment) and amputation-free rate at 6<br /><br>months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints will be the success rate, distal thromboembolic<br /><br>complications, other complications, 30 day mortality rate, conversion to open<br /><br>surgery, duration of hospital admission, serum fibrinogen concentrations, pain<br /><br>scores and quality of life.</p><br>