Is the clinical and cost-effectiveness of open surgery for severe occlusive disease of the aorta and iliac arteries superior to newer endovascular (keyhole) treatment? The EVOCC Trial

A randomised controlled trial assessing the clinical and cost-effectiveness of Endovascular vs. Open revascularisation in severe oCClusive aorto-iliac disease. The EVOCC Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14591444

Enrollment

628

Registered

2023-08-02

Start date

2023-10-01

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

Severe occlusive aorto-iliac disease Circulatory System

Interventions

Thirty NHS hospitals serving people with diverse ethnicities, social and economic backgrounds will take part. The researchers will ask people who need surgery to unblock their aorta or iliac arteries

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 05/09/2025: 1. Adults (=18 years) with symptomatic PAD (rest pain, tissue loss, or lifestyle-limiting claudication) 2. Severe aorto-iliac occlusive disease (TASC II C/D) 3. MDT consensus that both surgical and endovascular options are viable 4. Ability to provide informed consent 5. Ability to understand written English or availability of a translator to explain the trial documentation _____ Previous inclusion criteria: Main Trial 1. Age > = 18 years (no upper age limit) 2. Presence of symptomatic PAD (tissue loss and/or rest pain and/or lifestyle limiting claudication) 3. Severe aorto-iliac occlusive PAD defined as “Inter-Society Consensus for the Management of Peripheral Arterial Disease” (TASC II) class C or class D 4. Patient discussed in a local vascular Multi-Disciplinary Team (MDT) meeting and deemed suitable for open surgery or endovascular treatment. 5. Patient willing and able to give consent and commit to study follow-up. 6. An ability to understand written English or availability of a translator to explain the trial documentation Communication Study (Patients) 1. Patient willing and able to give consent 2. An ability to understand written English or availability of a translator to explain the study documentation 3. Involved with research visits with nurses and/or doctors that have provided consent for the HCP Communication Study (where related to audio-recording of research visits) Communication Study (Healthcare Providers) 1. Willing and able to give consent 2. Involved with research visits with patients that have provided consent for the Communication Study (where related to audio-recording of research visits)

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 05/09/2025: 1. Asymptomatic PAD 2. Non-consent 3. Comorbid conditions precluding intervention _____ Previous exclusion criteria: Allergy to iodinated intravascular contrast agent including: Iopromide, Iodamide, Iohexol, ioversol, Ioxilan, Iopamidole.

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 05/09/2025: Amputation-free survival (time to death or major lower limb amputation) measured in days from randomisation until first event or until the end of the trial (minimum 2 years) _____ Previous primary outcome measure: 1. Mortality (all cause), measured in days from randomisation until first event or until the end of the trial (minimum 2 years) where no event occurs 2. Cardiovascular events (myocardial infarction, stroke, admission for heart failure), measured in days from randomisation until first event or until the end of the trial (minimum 2 years) where no event occurs 3. Number of hospital admissions (including reasons for readmissions), following discharge from index surgical admission for up to 4.5 years at 6 and 12 months and annually thereafter. 4. All lower limb amputations (minor and major i.e. below and above ankle joint) measured in days from randomisation until first event or until the end of the trial (minimum 2 years) where no event occurs at baseline, trial intervention visit and day of discharge visit and all follow up visits (30 days, 6 and 12 months and annually thereafter) 5. Concomitant medications (specifically: use of statin, use of antithrombotic medication) at day of discharge, 30 days, 6 and 12 months and annually thereafter. 6. Estimated glomerular filtration rate (renal function) based on serum creatinine levels using the Chronic Kidney Disease Epidemiology (CKD-EPI) formula measured at 6 and 12 months and annually thereafter. 7. Low Density Lipoprotein measured at baseline and 6 months follow up visit. 8. HbA1C measured at baseline and 6 months follow up visit. 9. Cholesterol measured at baseline and 6 months follow up visit. 10. Ankle Brachial Pressure Index (ABPI) measured at baseline, 6 and 12 months and annually thereafter. 11. Types of endovascular devices used and/or name of surgery performed (open) at trial intervention visit and day of discharge. 12. Quality of life measured usin	—

Measure

Time frame

Current primary outcome measure as of 05/09/2025: Amputation-free survival (time to death or major lower limb amputation) measured in days from randomisation until first event or until the end of the trial (minimum 2 years) _____ Previous primary outcome measure: 1. Mortality (all cause), measured in days from randomisation until first event or until the end of the trial (minimum 2 years) where no event occurs 2. Cardiovascular events (myocardial infarction, stroke, admission for heart failure), measured in days from randomisation until first event or until the end of the trial (minimum 2 years) where no event occurs 3. Number of hospital admissions (including reasons for readmissions), following discharge from index surgical admission for up to 4.5 years at 6 and 12 months and annually thereafter. 4. All lower limb amputations (minor and major i.e. below and above ankle joint) measured in days from randomisation until first event or until the end of the trial (minimum 2 years) where no event occurs at baseline, trial intervention visit and day of discharge visit and all follow up visits (30 days, 6 and 12 months and annually thereafter) 5. Concomitant medications (specifically: use of statin, use of antithrombotic medication) at day of discharge, 30 days, 6 and 12 months and annually thereafter. 6. Estimated glomerular filtration rate (renal function) based on serum creatinine levels using the Chronic Kidney Disease Epidemiology (CKD-EPI) formula measured at 6 and 12 months and annually thereafter. 7. Low Density Lipoprotein measured at baseline and 6 months follow up visit. 8. HbA1C measured at baseline and 6 months follow up visit. 9. Cholesterol measured at baseline and 6 months follow up visit. 10. Ankle Brachial Pressure Index (ABPI) measured at baseline, 6 and 12 months and annually thereafter. 11. Types of endovascular devices used and/or name of surgery performed (open) at trial intervention visit and day of discharge. 12. Quality of life measured usin

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Secondary

Measure	Time frame
1. Mortality (all-cause), measured in days from randomisation until the first event or until the end of the trial (minimum 2 years) where no event occurs 2. Cardiovascular events (myocardial infarction, stroke, admission for heart failure), measured in days from randomisation until the first event or until the end of the trial (minimum 2 years) where no event occurs 3. Number of hospital admissions (including reasons for readmissions), following discharge from index surgical admission for up to 4.5 years at 6 and 12 months and annually thereafter. 4. All lower limb amputations (minor and major i.e. below and above ankle joint) measured in days from randomisation until the first event or until the end of the trial (minimum 2 years) where no event occurs at baseline, trial intervention visit and day of discharge visit and all follow up visits (30 days, 6 and 12 months and annually thereafter) 5. Concomitant medications (specifically: use of statin, use of antithrombotic medication) at the day of discharge, 30 days, 6 and 12 months and annually thereafter. 6. Estimated glomerular filtration rate (renal function) based on serum creatinine levels using the Chronic Kidney Disease Epidemiology (CKD-EPI) formula measured at 6 and 12 months and annually thereafter 7. Low Density Lipoprotein measured using standard blood sample assessments (standard of care, not research) at baseline and 6 months follow-up visit 8. HbA1C measured using standard blood sample assessments (standard of care, not research) at baseline and 6 months follow-up visit 9. Cholesterol measured using standard blood sample assessments (standard of care, not research) at baseline and 6 months follow-up visit 10. Ankle Brachial Pressure Index (ABPI) measured using a sphygmomanometer and a hand-held Doppler device at baseline, 6 and 12 months and annually up to month 54 11. Types of endovascular devices used and/or name of surgery performed (open) recorded at trial intervention visit and day of discharge 12.	—

Measure

Time frame

1. Mortality (all-cause), measured in days from randomisation until the first event or until the end of the trial (minimum 2 years) where no event occurs 2. Cardiovascular events (myocardial infarction, stroke, admission for heart failure), measured in days from randomisation until the first event or until the end of the trial (minimum 2 years) where no event occurs 3. Number of hospital admissions (including reasons for readmissions), following discharge from index surgical admission for up to 4.5 years at 6 and 12 months and annually thereafter. 4. All lower limb amputations (minor and major i.e. below and above ankle joint) measured in days from randomisation until the first event or until the end of the trial (minimum 2 years) where no event occurs at baseline, trial intervention visit and day of discharge visit and all follow up visits (30 days, 6 and 12 months and annually thereafter) 5. Concomitant medications (specifically: use of statin, use of antithrombotic medication) at the day of discharge, 30 days, 6 and 12 months and annually thereafter. 6. Estimated glomerular filtration rate (renal function) based on serum creatinine levels using the Chronic Kidney Disease Epidemiology (CKD-EPI) formula measured at 6 and 12 months and annually thereafter 7. Low Density Lipoprotein measured using standard blood sample assessments (standard of care, not research) at baseline and 6 months follow-up visit 8. HbA1C measured using standard blood sample assessments (standard of care, not research) at baseline and 6 months follow-up visit 9. Cholesterol measured using standard blood sample assessments (standard of care, not research) at baseline and 6 months follow-up visit 10. Ankle Brachial Pressure Index (ABPI) measured using a sphygmomanometer and a hand-held Doppler device at baseline, 6 and 12 months and annually up to month 54 11. Types of endovascular devices used and/or name of surgery performed (open) recorded at trial intervention visit and day of discharge 12.

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Countries

England, United Kingdom

Outcome results

None listed

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