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Treating acute ileofemoral DVT by mechanical trombectomy with Aspirex Device

Comparative analysis of success rate and complications of catheter guided thrombolysis and mechanical trombectomy with Aspirex Device in patients with acute ileofemoral deep vein thrombosis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016102630508N1
Enrollment
20
Registered
2016-12-16
Start date
2016-10-15
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep vein thrombosis. Deep vein thrombosis NOS

Interventions

Intervention 1: control goup: Catheter guided thrombolysis. Prior to thrombolysis all patients will be given heparin 1000 U/h. PTT will be evaluated and heparin dose will be adjusted based on patient
if there be an underlying stenotic lesion, balloon angioplasty and stenting will be performed as a supplementary procedure. Intervention 2: Intervention group: mechanical thrombectomy with Aspirex Dev
Treatment - Drugs
Treatment - Devices
control goup: Catheter guided thrombolysis. Prior to thrombolysis all patients will be given heparin 1000 U/h. PTT will be evaluated and heparin dose will be adjusted based on patient’s PTT. While
if there be an underlying stenotic lesion, balloon angioplasty and stenting will be performed as a supplementary procedure.
Intervention group: mechanical thrombectomy with Aspirex Device.Prior to thrombolysis all patients will be given heparin 1000 U/h. PTT will be evaluated and heparin dose will be adjusted based on pati

Sponsors

Vice Chancellor for research of Guilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: all the patients aged less than 60 years old with the onset of symptoms less than 2 weeks that initial diagnosis of acute ileofemoral deep vein thrombosis has been made by Doppler ultrasound and definite diagnosis has been made by venography and are a candidate for treatment Exclusion criteria: patients with heart, renal or pulmonary failure; and the patients with the diagnosis of DVT after two weeks of symptoms onset

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Duration of the treatment. Timepoint: During hospitalization. Method of measurement: The time recorded in the checklist.;The success rate of the treatment. Timepoint: During hospitalization after treatment. Method of measurement: venography.

Secondary

MeasureTime frame
Duration of hospitalization. Timepoint: During hospitalization. Method of measurement: The time recorded in the checklist.;Complications during the treatment. Timepoint: During treatment. Method of measurement: Physical examination and Lab tests.;Complete Thrombus lysis. Timepoint: During hospitalization after treatment. Method of measurement: Venography.;Improvement of the primary symptoms. Timepoint: During hospitalization, 2 weeks, 1 month, 45 days and 6 manoths after intervention. Method of measurement: Physical examination.;Complications during hospitalization. Timepoint: During hospitalization. Method of measurement: Physical examination and Lab tests.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Maziar Moayeri Far

Vascular surgery and Dialysis research center

sedi.3d@gmail.com+98 13 3354 2460

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026