The study investigates the inhibition of restenosis by the Paclitaxel-eluting PTA balloon Freeway versus stenting-PTA or PTA alone in the treatment of de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Rate of clinically driven target lesion revascularization (TLR) at 6 months
Secondary outcome
1. Technical success defined as the rate of successfully performed index
procedures after wire passage
2. Late lumen loss, i.e. the difference between the minimum lumen diameter
after intervention and during the follow-up at 6 months determined by
angiography
3. Clinical success defined as technical success without the occurrence of
serious adverse events during procedure
4. Ankle-Brachial Index improvement of >= 0.1 (ABI before procedure compared
with ABI at discharge and at 6, 12 (and 24) months
5. Primary and secondary patency rate defined as <50% diameter reduction and
peak systolic velocity <2.4 at 6, 12 (and 24) months
6. Change in WIQ i.e. walking impairment questionnaire from pre-intervention to
6, 12 (and 24) months follow-up improvement of walking distance before
procedure compared with walking distance at discharge and at 6 and 12 months
(if Treadmill test is available)
7. Rate of minor and major complications at 6 and 12 (and 24) months
8. Change in Rutherford classification grades of chronic limb ischemia from
pre-intervention to 6, 12 (and 24) months follow-up.
9. Rate of clinically driven target lesion revascularization (TLR) at 12 (and
24) months
Background summary
Although the immediate outcome of angioplasty of SFA and popliteal arteries are
generally satisfactory (success rate around 90%), the attempt to restore normal
flow using this technique often fails in the medium term (with a failure rate
of over 50% in some series) and the reason for this is restenosis.
Study objective
The study investigates the inhibition of restenosis by the Paclitaxel-eluting
PTA balloon Freeway versus stenting-PTA or PTA alone in the treatment of
de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (SFA)
or popliteal arteries.
Study design
Prospective, Randomized, Controlled, Multicentre, Open Study
Intervention
PTA with paclitaxel-eluting PTA balloon Freeway or stenting-PTA or PTA alone.
Study burden and risks
The risks involved with undergoing an angiogram.
Rheinwerkallee 2
D-53227 Bonn
DE
Rheinwerkallee 2
D-53227 Bonn
DE
Listed location countries
Age
Inclusion criteria
Patients with symptomatic ischemia, requiring treatment of SFA or popliteal artery
Exclusion criteria
Pregnancy, aneurisma disease of the abdominal aorta, iliac or popliteal arteries, contraindication for anti platelet therapy, stroke<3months, prior surgery target lesion,
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 | NL35524.075.11 |