Bioabsorbable stent implantation versus endarterectomy for atherosclerotic lesions in the common femoral artery

Bioabsorbable stent implantation versus endarterectomy for atherosclerotic lesions in the common femoral artery: an open prospective randomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN81656089

Enrollment

214

Registered

2013-09-04

Start date

2011-05-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Atherosclerosis. Peripheral arterial occlusive disease. Fontaine stages IIb-IV Circulatory System Arteriosclerosis

Interventions

1. Standard common femoral artery endarterectomy with patch closure (vein/artificial) 2. Percutaneous common femoral artery stent implantation using a bioabsorbable lactic acid stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with peripheral arterial occlusive disease in the common femoral artery due to atheroscloerosis

Exclusion criteria

Exclusion criteria: 1. Pregnancy 2. Active malignancy 3. Infectious diseases (hepatitis, HIV) 4. Inability to comply with study requirements (e.g. regular follow up)

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 28/01/2014: 1. Surgical site infections (SSI, local groin complications associated with intervention, i.e. wound healing, bleeding, infection) Outcomes are measured regularly at baseline, one month, 3 months, 6 months and biannually thereafter Previous primary outcome measures: 1. Intervention patency 2. Effect of intervention (improvement of circulation as measuerd by the ankle/brachial index) 3. Limb salvage 4. Survival Outcomes are measured regularly at baseline, 1 month, 3 months, 6 months and biannually thereafter	—

Measure

Time frame

Current primary outcome measures as of 28/01/2014: 1. Surgical site infections (SSI, local groin complications associated with intervention, i.e. wound healing, bleeding, infection) Outcomes are measured regularly at baseline, one month, 3 months, 6 months and biannually thereafter Previous primary outcome measures: 1. Intervention patency 2. Effect of intervention (improvement of circulation as measuerd by the ankle/brachial index) 3. Limb salvage 4. Survival Outcomes are measured regularly at baseline, 1 month, 3 months, 6 months and biannually thereafter

—

Secondary

Measure	Time frame
Current secondary outcome measures as of 28/01/2014: 1. Technical success 2. Hemodynamic improvement (measured by ankle-brachial index) 3. Primary sustained clinical improvement (relief of symptoms measured by standard forms, e.g. SF19) 4. Secondary sustained clinical improvement (relief of symptoms measured by standard forms, e.g. SF19) 5. Patency 6. Limb salvage 7. Hospital resource use (length of stay, outpatient clinic visits, costs) 8. Survival Outcomes are measured regularly at baseline, 1 month, 3 months, 6 months and biannually thereafter Previous secondary outcome measures: 1. Local groin complications associated with intervention (wound healing, bleeding, infection) 2. Relief of symptoms (measured by standard forms e.g. SF19) 3. Hospital resource use (length of stay, outpatient clinic visits, costs) 4. Secondary intervention for improvement of circulation Outcomes are measured regularly at baseline, 1 month, 3 months, 6 months and biannually thereafter	—

Measure

Time frame

Current secondary outcome measures as of 28/01/2014: 1. Technical success 2. Hemodynamic improvement (measured by ankle-brachial index) 3. Primary sustained clinical improvement (relief of symptoms measured by standard forms, e.g. SF19) 4. Secondary sustained clinical improvement (relief of symptoms measured by standard forms, e.g. SF19) 5. Patency 6. Limb salvage 7. Hospital resource use (length of stay, outpatient clinic visits, costs) 8. Survival Outcomes are measured regularly at baseline, 1 month, 3 months, 6 months and biannually thereafter Previous secondary outcome measures: 1. Local groin complications associated with intervention (wound healing, bleeding, infection) 2. Relief of symptoms (measured by standard forms e.g. SF19) 3. Hospital resource use (length of stay, outpatient clinic visits, costs) 4. Secondary intervention for improvement of circulation Outcomes are measured regularly at baseline, 1 month, 3 months, 6 months and biannually thereafter

—

Countries

Austria

Outcome results

None listed

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