De Tack-IT Endovascular Stapler consists of a very short stent-like frame (Tack ring or endovascular ring) which has the properties of a stent (to prevent elastic recoil and to treat intimal damage), but lacks the disadvantages of the usual longer…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Absence of need for target lesion revascularization during 30 days follow-up.
Absence of distal trombo-emblization during 30 days follow-up.
Technical success: <30% residual stenosis of the treated SFA after placement of
a Tack-IT ring during completion angiography.
Secondary outcome
Amputation free survival at 12 and 24 months follow-up.
Freedom from restenosis (>50%) at 12 and 24 months follow-up
Changes in ankle brachial index from baseline at 12 and 24 month follow-up.
Changes in Rutherford class from baseline at 12 and 24months follow-up.
All cause mortality at 12 and 24 months follow-up.
Background summary
Peripheral arterial disease affects between 3-7% of the population above the
age of 75. Of these patients, 15-30% migth suffer from critical limb ischemia
if peripheral arterial disease hasn't been treated. In most of the patients the
obstruction is localized in the femoro-popliteal arteries. The results of
percutaneous transluminal angioplasty (PTA) for long-segment (>10 cm)
obstructions of the superficial femoral artery (SFA) arre rather disappointing
with a one-years patency of 20-33%. This is mainly due to "elastic recoil" of
the arterial wall post-PTA. Besides, the SFA is a dynamic artery and suffers
from shortening, torsion and bending forces during movement of the leg and
especially the knee joint. In order to improve PTA results stents have been
developped and used. Stents migth prevent elastic recoil post-PTA and can be
used to tack intimal damage like dissections post-PTA. One of the major
disavdantages of the use of stents in the dynamic SFA is the risk for stent
fracture. Another drawback is intimal hyperplasia inside the stents, which
might cause in-stent restenosis.
De Tack-IT Endovascular Stapler bestaat uit een zeer kort stent achtige frame
(Tack ring genaamd) dat wel stent eigenschappen heeft om de rcoil tegen te gaan
en de intima van de vaatwand te behandelen en vast te zetten, maar niet het
nadeel heeft van de langere stents, zoals stentbreuk. Doordat de Tack-IT
Endovascular Stapler zeer kort is (elke Tack ring is 6 mm lang), kan het ook
worden gebruikt op het buigpunt van de arteria femoralis superficialis en de
arteria poplitea (knie slagader).
De Tack-IT Endovascular Stapler zou dus het resultaat van PTA behandeling
kunnen optimaliseren maar dan zonder de nadelen van de huidige stents. Hiermee
zou het resultaat van PTA behandeling van de AFS kunnen worden verbeterd.
Study objective
De Tack-IT Endovascular Stapler consists of a very short stent-like frame (Tack
ring or endovascular ring) which has the properties of a stent (to prevent
elastic recoil and to treat intimal damage), but lacks the disadvantages of the
usual longer stents, like stent fracture. The Tack-IT Endovascular Stapler is 6
mm long and can be used at the bending point of the superficial femoral artery
and the popliteal artery.
De Tack-IT Endovascular Stapler could optimize the results of the current
standard PTA treatment, but without the disadvantages of the usual stents. In
that way it could lead to better results in the endovascular treatment of SFA
obstructions. Efficacy and safety of the device will be determined in this
study.
Study design
Prospective, single-arm, non-randomized, non-blinded study. All patients will
be treated with the Tack-IT Endovascular Stapler.
Intervention
In patients who meet the inclusion criteria (and don't have any exclusion
criterium) Tack-rings will be placed in the SFA with use of the Tack-IT
Endovascular Stapler. A maximum of 8 Tack-rings will be placed.
Study burden and risks
Patients in this study will have similar work-up as all other (non-study)
patients before PTA of the SFA in our hospital. The follow-up scheme is also
similar to the regular follow-up post PTA of the SFA. The PTA procedure itself
will also be similar to non-study patients. The only difference comparing to
standard PTA treatment of the SFA is the fact that no long stent will be used,
but the short Tack-IT rings. Placement of the Tack-IT rings is quite similar to
the placement of regular stents, however, the Tack-IT rings are much shorter
compared to the regular stents. So far, no device related complications have
been mentioned with the Tack-IT device. CE approval has been obtained for the
Tack-IT device.
150 Strafford Avenue #303
Wayne, PA 19087
US
150 Strafford Avenue #303
Wayne, PA 19087
US
Listed location countries
Age
Inclusion criteria
General inclusion criteria:
Age >18 years.
Rutherford classification 2, 3 or 4 concerning peripheral arterial disease.
ABI < 0.90
Angiographic inclusion criteria:
Stenosis of the SFA >70%
Total length of the SFA obstruction <10 cm
Possibility to pass the SFA obstruction with guidewire
Residual stenosis of <30% post-PTA
No aneurismal SFA disease, nor acute thrombosis
Diameter of the treated SFA in between 2.5 and 5.5 mm
Run off by at least one crural artery
Exclusion criteria
Rutherford classification 5 or 6.
Former treatment of the SFA.
Former femoro-popliteal bypass.
Planned amputation of the ipsilateral leg.
Infection of the ipsilateral leg.
Significant obstruction of the inflow or outflow arteries of the ipsilateral leg without treatment.
Acute thrombosis
Immune compromised patient
Know coagulopathy, thrombocytopenia, INR > 1.5
Myocardial infarction 30 days prior to treatment
Stroke 3 months prior to treatment
Renal insufficiency (kreat >220 umo/l)
Pregnancy or breast feeding
Number of needed Tacks will be >8
Severe, circumferential calcification of the target lesion >5 cm.
Subject requires treatment of tibial or outflow vessels at the index procedure.
Subject has a known hypersensitivity or contraindication to nitinol.
Subject to return for 24 Month Visit has been previously reported as having a non-patent target lesion or a target lesion revascularization.
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 | NL41933.100.12 |