The aim of this study is to analyze and evaluate the feasibility and efficacy of treatment with a DEB of edge stenosis of covered stents in the SFA.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patency rates after treatment with DEB (after 30-days and after 1 year)
Secondary outcome
Complications
Background summary
Patency rates of angioplasty and bare metal stenting of occlusive lesions of
the superficial femoral artery (SFA) have improved in recent years. Results,
however, are limited by the occurrence of in-stent restenosis (ISR), mainly in
longer lesions (>10cm). With the introduction of covered stents the incidence
of ISR is reduced, since the covering material will shield the stent from
tissue in-growth. Re-stenosis will be limited to the edges of the covered stent
(edge stenosis), which is often easier to treat compared with a diffuse ISR.
Randomized studies have shown a superior patency of covered stents compared
with bare metal stenting in long lesions and a comparable patency with
prosthetic above-knee bypass. The optimal treatment modality of edge stenosis
remains to be elucidated. Currently an extension of the covered stent is
frequently used with the disadvantage of high costs and the possible
overstenting of collaterals in the popliteal artery in case of a distal edge
stenosis.
Recent studies have described the efficacy of Drug-eluting balloons (DEB) for
treatment of ISR. These studies have shown a higher primary patency rate than
angioplasty and have shown that the use of DEB limits usage of stents. Previous
studies have also described better clinical outcome such as an
higher Ankle-Brachial index (ABI), increased walking capacity and increased
Quality of Life(QOL).
The effect of paclitaxel lays in the inhibitation of neointimal proliferation.
When delivered locally, in small concentrations, this antineoplastic drug
provides sustained inhibition of vascular smooth muscle cell proliferation and
migration. Studies have also compared the paclitaxel-eluting balloons with
conventional uncoated balloon angioplasty, this resulted in significant
reduction in restenosis.
The efficacy of edge stenosis of endoluminal graft with DEB still has not been
studied to date. Treating endoluminal edge stenosis with DEB could inhibit
extension of stentgrafts and therefore sparing collaterals and postpone
surgical interventions. Treatment with DEB may result in high
cost-effectiveness. The goal of the current study is to analyze and evaluate
the effect of DEB on the occurrence edge stenosis in order to provide data for
a randomized controlled trial compared with treatment by an extension of the
endograft by additional stenting in the near future.
Study objective
The aim of this study is to analyze and evaluate the feasibility and efficacy
of treatment with a DEB of edge stenosis of covered stents in the SFA.
Study design
Prospective feasibility study.
Intervention
An angioplasty of the lesion will be performed, according to the local
protocols. Afterwards the lesion will be treated with a paclitaxel-eluting
balloon .
Study burden and risks
Based on our current knowledge, participating in this study with
paclitaxel-eluted balloons has no additional risks. Previously studies have
already shown better clinical outcomes compared to conventional angioplasty.
Therefore we think that the patients wil profit from this intervention. In
every clinical study unexpected and still unknown complications can occur.
Obviously every effort possible, will me made to minimize the risks.
wagnerlaan 55
Arnhem 6815 AD
NL
wagnerlaan 55
Arnhem 6815 AD
NL
Listed location countries
Age
Inclusion criteria
Patients over 18 years of age
Signed informed consent
Edge stenosis of the endograft in the SFA with a peak systolic velocity ratio (PSV ratio) of >2.5
Target vessel diameter > or equal to 4 mm and < or equal to 7 mm
Exclusion criteria
-Pregnancy or breast feeding women
-Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, -paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
-Patient unsuitable for administration of contrast agent
-Stroke or heart attack within 3 months prior to enrollment
-Enrolled in another investigational drug, device or biologic study
-Any surgical procedure or intervention performed within 30 days prior to or post index procedure
-Failure to successfully cross the target lesion
-Angiographic evidence of severe calcification
-Dementia or altered mental status that would prohibit giving conscious informed consent
-Need for adjunctive major surgical or vascular procedures within one month
-Untreated flow-limiting aortoiliac occlusive disease
-Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancies, dementia etc.) or other medical condition that would preclude compliance with study protocol
-Any previously known coagulation disorder, including hypercoagulability
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 | NL44386.091.13 |