To demonstrate the equality of a heparin bonded ePTFE covered stent-graft with the femoropopliteal bypass for long lesions in the superficial femoral artery
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoints:
Primary, primary-assisted and secondary patency
Secondary outcome
Secundaire endpoints:
Complications
Clinical improvement
Surgical and endovascular re-interventions
Quality of Life
target lesion revascularization
Subgroup analysis:
-patients with disabling claudication (Rutherford 3) will be analyzed
separately using pain-free and maximal walking distance as additional endpoint
- patients with ischemic restpain and necrosis (Rutherford 4-6) will be
analyzed using limb salvage and major amputation as endpoints
Background summary
The treatment of first choice of long superficial femoral artery obstructions
still consists of surgical venous femororpopliteal bypass. The one year patency
of this procedure is 87% and the four year patency 70%.
In recent years endovascular techniques have advanced and provided new
treatment options for peripheral vascular disease. Results of an angioplasty of
the SFA seem to depend on the length of the lesion. For short lesions the
results are good with an one year patency of 80%. But for longer lesions the
one year patency of nitinol stents is only 63%.
One of the major limiting issues appears to be in-stent re-stenosis. With the
development of ePTFE covered stents the patency has improved to 83% in one year
and 63% in two years (comparable to the prosthetic bypass. Heparin bonded
stents have improved the results to a two year patency of 69-81%.
Recently the heparin bonded stent has been integrated with the ePTFE covered
stent. Using this technique the results may improve to the level of the current
gold standard, the venous femoropopliteal bypass. Advantages of the endoluminal
techniques would be related to the minimal invasieve character: less pain,
earlier recovery and less early complications.
Study objective
To demonstrate the equality of a heparin bonded ePTFE covered stent-graft with
the femoropopliteal bypass for long lesions in the superficial femoral artery
Study design
Prospective randomised controlled trail
Intervention
Patients are randomised between surgical venous femoropopliteal bypass and
endoluminal stent-graft
Study burden and risks
Patients who would receive an endoluminal bypass, but in who the procedure
fails, will receive a surgical bypass during the same session.
The first three months (one, three and six months postoperatively) patients
will have to complete a questionnaire before their OPD visit.
St Antonielaan 190
6821 GL Arnhem
NL
St Antonielaan 190
6821 GL Arnhem
NL
Listed location countries
Age
Inclusion criteria
patients over 18 years of age
informed consent
>10 cm stenosis or occlusion of the SFA or popliteal artery, nort extending below knee level
rutherford category 3-6
indication for surgical bypass
distal runoff of one or more vessels
resting ABI <0,8 in the study limb prior to procedure
de novo stenosis or restenosis (>50%) of occlusion of the native SFA
orifice and proximal 1 cm of SFA are patent
popliteal artery is patent at P2 segment to the trifurcation
diameter of native SFA and popliteal artery are 4.3-7.5 mm
Exclusion criteria
patient unsuitable for administration of contrast agent (previous lifethreathening reaction)
pregnancy
dementia or altered mental status that would prohibit giving conscious informed consent
need for major surgical or vascular procedures within one month
untreated flowlimiting aortoiliac occlusive disease
any previous stenting or surgery in the target vessel
severe ipsilateral common femoral/profunda disease requiring surgical intervention
perioperative unsuccesful ipsilateral percutaneous vascular procedure to treat inflow disease prior to enrollment
femoral or popliteal aneurysm of target vessel
non-artherosclerotic disease resulting in occlusion (eg embolism, Buerger's disease, vasculitis)
prior ipsilateral femoral artery bypass
severe medical comorbidities or other medical condition that would preclude compliance with study protocol
serum creatinine >2,5 mg/dL within 45 days prior to study procedure unless subject is currently on dialysis
major distal amputation (above the transmetatarsal) in ther study or non-study limb
septicemia or bacteremia
any previously known coagulation disorder
contraindication to anticoagulation or antiplatelet therapy
Known allergies to stent/stentgraft components
patients with known hypersensitivity to heparin including those who have had a previous incidence of heparin induced thrombocytopenia type II
planned surgical procedure or amputation after enrollment of the patient
Design
Recruitment
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 | NL29652.091.09 |