Our primary objective is to assess the absence of binary restenosis rate, the reocclusion rate and target-lesion revascularization rate of endovascular treatment of advanced atherosclerotic lesions of the common iliac artery with a balloon…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters/endpoints: The primary endpoints are absence of binary
restenosis rate, reocclusion rate and target-lesion revascularization rate.
Primary study parameters are age, gender, relevant co-morbidity, and several
patient, disease and procedure related parameters.
Secondary outcome
Secondary endpoints are clinical success, procedural success, hemodynamic
success, major amputation rate, complication rate and mortality rate.
Background 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.
Study objective
Our primary objective is to assess the absence of binary restenosis rate, the
reocclusion rate and target-lesion revascularization 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 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.
Study design
A prospective, randomized, controlled, triple-blind, multi-center trial
Intervention
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.
Study burden and risks
Participating patients will need to make five study-related hospital visits.
Four Duplex Ultrasonography (DUS) and five ankle-brachial index (ABI)
measurements with treadmill test will be performed. When compared to our
standard work-up and follow-up, patients need to make two extra hospital
visits, and will receive two extra DUS and ABI measurements with treadmill
test. When treadmill test or DUS shows possible restenosis, patients will
receive additional CT-angiography, MR-angiography and/or Digital Substraction
Angiography. This is standard procedure. Furthermore, patients will be asked to
fill out two questionnaires five times. We do not expect an increased risk for
patients by participating in this study. Patients who participate may benefit
by being treated with a stent that may have a lower restenosis rate.
Maasstadweg 21
Rotterdam 3079DZ
NL
Maasstadweg 21
Rotterdam 3079DZ
NL
Listed location countries
Age
Inclusion criteria
- Age over 18
- Symptomatic, atherosclerotic lesion of the common iliac artery, either a hemodynamically significant stenosis with a length of more than 3 cm, or an occlusion
- Signed informed consent form
Exclusion criteria
- Stenosis with a length of less than 3 cm
- Presence of a metastatic malignancy, or other disease that limits life expectancy to less than two years.
- Previous endovascular or surgical treatment of the common iliac artery on the affected side.
- Inability or unwillingness to comply with the follow-up schedule.
- Mental disability or language barrier that hinders the ability to understand and comply with the informed consent.
- Pregnancy or breast-feeding.
- Severe renal failure (e-GFR <30 mL/min/1.73 m2)
- Known allergy to iodinated contrast agents or to PTFE.
- Contra-indication for anti-coagulation.
- Acute limb ischemia
- Occlusion of the abdominal aorta
- Aneurysm of the abdominal aorta that is not amenable to endograft placement
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL37828.101.12 |