Mechanical debulking to eliminate thrombolysis and/or open surgery from initial therapy of acute and subacute ischaemia of lower limbs

Prospective, single-arm and non-sponsored trial to evaluate potential of selected mechanical debulking techniques to eliminate thrombolysis and/or open surgery from initial therapy of acute and subacute ischaemia of lower limbs

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15496770

Enrollment

300

Registered

2017-05-11

Start date

2009-04-01

Completion date

Unknown

Last updated

2019-05-05

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

Conditions

Acute and subacute ischeamia of lower limbs Circulatory System Acute and subacute ischeamia of lower limbs

Interventions

After recruitment, all patients undergo digital subtraction angiography and endovascular treatment. The procedure starts with local anesthesia of the groin tissue and insertion of percutaneous sheath.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Symptomatic lower limb(s) ischaemia: acute, categories IIA or IIB (the Rutherford classification of acute limb ischaemia), onset of symptoms: 14 days or less 2. Symptomatic subacute lower limb ischemia: categories 3-6 (the Rutherford classification for chronic limb ischaemia), severe claudication, critical limb ischemia, ischemic tissue defect, rest ischemic pain, symptoms duration: from 15 days to 3 months 3. Aged 18 years and over 4. Written informed consent given prior to study entry (or court agreement in unconscious patient) 5. Occluded graft and/or native artery supplying lower limb (supratibial location, lumen diameter 4 mm or more at the site of occlusion, stented or non-stented, with or without calcifications, with or without additional infrapopliteal occlusions/stenoses) 6. Diagnosis of vascular occlusion on digital subtraction angiogram after informed consent is obtained 7. Ability to traverse the occlusion intraluminally with guidewire

Exclusion criteria

Exclusion criteria: 1. Serious hemodynamic circulatory incompetence contraindicating application of x-ray contrast material 2. Anatomy excluding endovascular approach and treatment 3. Category III acute lower limb ischemia (irreversible) 4. Occluded vessel diameter less 4 mm, arterial spasm resistant to nitroglycerine 5. Written informed consent or court agreement were not obtained 6. Situation when primary surgical approach is necessary

Design outcomes

Primary

Measure	Time frame
1. Number of thrombolytic and surgical revascularization procedures, deaths and amputations is registered at discharge, 30 days and 12 months 2. Amputation-free survival (percentage of patients who survived with both limbs) is evaluated at 30 days and 12 months	—

Secondary

Measure	Time frame
1. Clinical success is defined as technical success of the procedure and relief of acute ischemic symptoms at discharge and at 30 days 2. Overall clinical success is defined as relief of acute ischemic symptoms and the patient´s return to at least his/her pre-occlusive clinical baseline level after the therapy - including adjunctive therapeutic procedures 3. Technical success is defined as restoration of antegrade flow and residual diameter stenosis of 30% or less 4. Hemodynamic success is defined by increase of ABI (ankle-brachial index) for more than 0.10 after the intervention. It reflects overall effect of all recanalization techniques used. ABI is established by doppler as a dimensionless ratio of distal systolic blood pressure and arm systolic blood pressure 5. Primary patency refers to continued flow through treated target vessel without intervention at given time interval (30 days, 12 months), established on the basis of symptoms, physical examination, ultrasound examination or angiography 6. Secondary patency refers to continued flow through treated target vessel that was restored after reocclusion (durability of second intervention). 7. Number of infrapopliteal interventions is registered immediately after the intervention on angiography 8. Difference in observed parameters between thrombotic and embolic subgroups is assessed by statistical evaluation. 9. Difference in observed parameters between patients with acute and subacute ischaemia is assessed by statistical evaluation 10. Adverse events are registered during intervention, at 30 days and 12 months 10.1. Hemorrhagic and nonhemorrhagic complications are monitored and recorded in patient´s hospital documentation, hospital database, intervention protocol, hospital ambulatory care database and database of laboratory examinations	—

Measure

Time frame

1. Clinical success is defined as technical success of the procedure and relief of acute ischemic symptoms at discharge and at 30 days 2. Overall clinical success is defined as relief of acute ischemic symptoms and the patient´s return to at least his/her pre-occlusive clinical baseline level after the therapy - including adjunctive therapeutic procedures 3. Technical success is defined as restoration of antegrade flow and residual diameter stenosis of 30% or less 4. Hemodynamic success is defined by increase of ABI (ankle-brachial index) for more than 0.10 after the intervention. It reflects overall effect of all recanalization techniques used. ABI is established by doppler as a dimensionless ratio of distal systolic blood pressure and arm systolic blood pressure 5. Primary patency refers to continued flow through treated target vessel without intervention at given time interval (30 days, 12 months), established on the basis of symptoms, physical examination, ultrasound examination or angiography 6. Secondary patency refers to continued flow through treated target vessel that was restored after reocclusion (durability of second intervention). 7. Number of infrapopliteal interventions is registered immediately after the intervention on angiography 8. Difference in observed parameters between thrombotic and embolic subgroups is assessed by statistical evaluation. 9. Difference in observed parameters between patients with acute and subacute ischaemia is assessed by statistical evaluation 10. Adverse events are registered during intervention, at 30 days and 12 months 10.1. Hemorrhagic and nonhemorrhagic complications are monitored and recorded in patient´s hospital documentation, hospital database, intervention protocol, hospital ambulatory care database and database of laboratory examinations

—

Countries

Czech Republic

Outcome results

None listed

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