Covered versus uncovered stents in the common iliac artery.|
|- candidate number||12191|
|- NTR Number||NTR3381|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-apr-2012|
|- Secondary IDs||2012_06 / NL37828.101.12; METC TWOR / ABR|
|- Public Title||Covered versus uncovered stents in the common iliac artery.|
|- Scientific Title||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.|
|- hypothesis||Use of covered balloon-expandable stents for advanced atherosclerotic lesions of the common iliac artery lead to lower binary restenosis rates when compared to uncovered balloon-expandable stents.|
|- Healt Condition(s) or Problem(s) studied||Limb ischemia, Atherosclerosis |
|- 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||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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2012|
|- planned closingdate||1-mei-2016|
|- Target number of participants||174|
|- 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.
Endovascular stenting of the common iliac artery using one of several selected uncovered balloon-expandable stents.
|- Primary outcome||Absence of binary restenosis rate.|
|- Secondary outcome||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.
|- Timepoints||1 month, 6 months, 12 months, 24 months.
Primary and secondary outcomes will be assessed using the following
modalities: Pre- and post-intervention Digital Subtraction Angiography
with 3D-reconstruction, RAND-36 (Quality of Life Questionnaire), WIQ
(Walking Impairmant Questionnaire, questionnaire for intermittent
claudication complaints), Ankle-Brachial Index and Duplex
Ultrasonography. If re-stenosis or occlusion is suspected,
CT-angiography, MR-angiography or Digital Subtraction Angiography will
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Joost Bekken|
|- CONTACT for SCIENTIFIC QUERIES|| Joost Bekken|
|- Sponsor/Initiator ||Maasstad Hospital, Sint Antonius Ziekenhuis|
(Source(s) of Monetary or Material Support)
|Atrium Medical Inc., Hudson, NH|
|- Brief summary||Rationale:|
Iliac artery atherosclerotic disease may cause intermittent claudication and critical limb ischemia. It can lead to serious complications such as infection, amputation and even death. Revascularization relieves symptoms and prevents these complications. Historically, open surgical repair, in the form of endarterectomy of bypass, was used. Over the last decade, endovascular repair has become the first choice of treatment for iliac arterial occlusive disease. No definitive consensus has emerged about the best endovascular strategy and which type of stent, if any, to use. However, in more advanced disease, literature is most supportive of primary stenting with a balloon-expandable stent in the common iliac artery. Recently, a PTFE-covered balloon-expandable stent (Advanta V12, Atrium Medical Inc., Hudson, NH) has been introduced for the iliac artery. Covering stents with PTFE has been shown to lead to less neo-intimal hyperplasia and this might lower restenosis rates. However, only one RCT of mediocre quality has been published on this stent in the common iliac artery. Our hypothesis is that covered balloon-expandable stents lead to better results when compared to uncovered balloon-expandable stents.
Our primary objective is to assess the absence of binary restenosis rate of endovascular treatment of advanced atherosclerotic lesions of the common iliac artery with a balloon expandable PTFE-covered stent (Advanta V12), when compared to balloon-expandable uncovered stents after a 2-year follow-up.
Our secondary objectives are to assess the reocclusion rate, target-lesion revascularization rate, morphological outcome, clinical outcome, hemodynamic outcome, major amputation rate, complication rate and mortality rate of endovascular treatment of advanced atherosclerotic lesions of the common iliac artery with a balloon expandable PTFE-covered stent (Advanta V12), when compared to balloon-expandable uncovered stents after a 2-year follow-up.
A prospective, randomized, controlled, triple-blind, multi-center trial.
Human volunteers aged over 18 years, with symptomatic advanced atherosclerotic disease of the common iliac artery, defined as stenoses longer than 3 cm and occlusions. A total of 174 patients will be included.
The control group will undergo endovascular dilatation or revascularization of the common iliac artery, followed by placement of one or more uncovered balloon-expandable stents. The study group will undergo the same treatment, however one or more PTFE-covered balloon-expandable stents will be placed. When necessary, the aorta, external iliac artery, common femoral artery, superficial femoral artery and deep femoral artery will be treated, using the standard treatment.
Main study parameters/endpoints:
The primary endpoints is absence of binary restenosis rate. Secondary endpoints are reocclusion rate, target-lesion revascularization rate, clinical success, procedural success, hemodynamic success, major amputation rate, complication rate and mortality rate. Main study parameters are age, gender, relevant co-morbidity, and several patient, disease and procedure related parameters.
|- Main changes (audit trail)|
|- RECORD||3-apr-2012 - 19-apr-2012|
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