Covered versus uncovered stents in the common iliac artery.

Dutch Iliac Stent trial: COVERed balloon-expandable versus uncovered balloon-expandable stents. A prospective, randomized, controlled, triple-blind, multi-center trial comparing PTFE-covered balloon-expandable stents versus uncovered balloon-expandable stents in patients with advanced occlusive disease of the common iliac artery in terms of morphologic, clinical, and hemodynamic outcome after a 2-year follow-up.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24897

Enrollment

174

Registered

2012-04-03

Start date

2012-05-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

PAOD Peripheral artery occlusive disease Atherosclerotic disease Perifeer vaatlijden Atherosclerose

Interventions

Intervention group: Endovascular stenting of the common iliac artery using the Advanta V12 stent (Atrium Medical Inc., Hudson, NH), a PTFE-covered balloon-expandable stent. Control group: Endovascu

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age over 18; 2. Symptomatic, atherosclerotic lesion of the common iliac artery, either a hemodynamically significant stenosis with a length of more than 3 cm, or an occlusion; 3. Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Stenosis with a length of less than 3 cm; 2. Presence of a metastatic malignancy, or other disease that limits life expectancy to less than two years; 3. Previous endovascular or surgical treatment of the common iliac artery on the affected side; 4. Inability or unwillingness to comply with the follow-up schedule; 5. Mental disability or language barrier that hinders the ability to understand and comply with the informed consent; 6. Pregnancy or breast-feeding; 7. Severe renal failure (e-GFR <30 mL/min/1.73 m2); 8. Known allergy to iodinated contrast agents or to PTFE; 9. Contra-indication for anti-coagulation; 10. Acute limb ischemia; 11. Occlusion of the abdominal aorta; 12. Aneurysm of the abdominal aorta that is not amenable to endograft placement.

Design outcomes

Primary

Measure	Time frame
Absence of binary restenosis rate.	—

Secondary

Measure	Time frame
1. Reocclusion rate; 2. Target-lesion revascularization rate; 3. Clinical success; 4. Procedural success; 5. Hemodynamic success; 6. Major amputation rate; 7. Complication rate; 8. Mortality rate.	—

Contacts

Public ContactJoost Bekken

Maasstad Ziekenhuis Postbus 9100

BekkenJ@maasstadziekenhuis.nl+31 (0)10 2912624

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)