To compare the safety and efficacy of the Tack Endovascular System* in subjects with peripheral artery disease (PAD) to a pre-defined performance goal (PG).
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety:
Freedom from the occurrence of any new-onset major adverse event(s) (MAEs)
defined as index limb amputation (above the ankle), CEC adjudicated
clinically-driven target lesion revascularization (CD-TLR), or all-cause death
at 30 days.
Efficacy:
Primary patency defined as freedom from CEC adjudicated clinically-driven
target lesion revascularization (CD-TLR) and freedom from core lab adjudicated
duplex ultrasound derived binary restenosis at 12 months (defined as PSVR
>2.5).
Secondary outcome
Device Success:
Successful deployment of the Tack(s) at the intended target site(s) and
successful withdrawal of the delivery catheter from the introducer sheath. If
the study device is introduced but the subject does not receive a Tack due to
user error and not a device malfunction, this device will not be included in
the device success assessment.
Procedural Success:
Demonstrated vessel patency (<30% residual DS, by visual estimate) without the
use of a bailout stent or the occurrence of MAE upon completion of the index
procedure.
In addition, the following observational endpoints will be assessed at various
time points through 24 months (See Section 8.1 Time and Events Schedule):
All cause death
Amputation of the target limb (above the ankle)
Clinically-driven target vessel revascularization (CD-TVR)
Clinically-driven target target lesion revascularization
Target vessel revascularization (TVR)
Target lesion revascularization (TLR)
Changes from baseline in Rutherford Classification
Changes from baseline in Ankle Brachial index (ABI) measurement
Changes from baseline in Peripheral Artery Questionnaire (PAQ)
Changes from baseline in the EQ-5D-3L quality of life questionnaire
Changes from baseline in the Walking Impairment Questionnaire (WIQ)
Tack integrity via X-ray
Duplex Ultrasound (DUS) derived lesion and vessel patency
Background summary
To fully understand the impact of post-PTA dissections, investigation is
required on their associated potential clinical implications. Because of higher
incidence of complications due to dissections, their impact on clinical outcome
has been an important issue in percutaneous coronary interventions. More severe
dissections seem to be associated with higher restenosis rates and early
occlusions. The most comprehensive assessment of clinical implications in the
peripheral vasculature was the previously discussed in the THUNDER study.
Angiographic analysis of study patients included angiograms from before and
after the intervention and from the 6-month follow-up. The primary clinical
outcome was TLR at 6- and 24- month time points. The parameters assessment were
late lumen loss (LLL), minimum lumen diameter (MLD) and an area analysis to
evaluate the entire longitudinal luminal area of the vessel dilated. There were
no significant differences in the post-procedure angiographic parameters
between patients with grades A or B dissection vs. grade C, D, or E (although
the degree of residual stenosis (Narrowing) tended to be larger with higher
grade dissections).
The THUNDER study concluded that untreated dissections were observed to be
correlated with increased complications and with decreased long-term patency.
For all dissection grades, clinical implications were noted in patients with
observed dissections. To further understand the implications, the literature
results were reviewed and compiled to compare to the extent possible the
clinical/angiographic results of PTA with no post-procedure dissections (from
general literature references) to those of post-PTA dissection (from the
THUNDER Trial) in the femoropopliteal arteries. Only one time period had
defined data for both subsets (6 months).
The results in suggest that even with low grade dissections (Type A/B) clinical
implications may be observed with lower patency rates than those observed for
PTA and higher rates of TLR when compared to PTA without dissections. While
these results are more pronounced for C/D/E dissections, the clinical impact of
all dissections is notable. Primary patency was lower and target lesion
revascularization higher for the patient population with observed dissections.
Based on the clinical and literature reported data indicative of an
under-reporting of higher grade dissections and the clinical links to observed
lower patency rates, there exists a clinical need to provide for focal
treatment of post-PTA non-flow-limiting dissections in addition to those that
are flow-limiting. The Tack Endovascular System is designed to provide a
treatment option for all grade dissections.
Study objective
To compare the safety and efficacy of the Tack Endovascular System* in subjects
with peripheral artery disease (PAD) to a pre-defined performance goal (PG).
Study design
This is a prospective, multi-center, single-arm, non-blinded study designed to
investigate the safety and efficacy of the Tack Endovascular System*.
Intervention
The Tack Endovascular System* is intended for use in the superficial femoral
and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm for the
repair of post percutaneous transluminal balloon angioplasty (PTA)
dissection(s) type(s) A through F.
Study burden and risks
Minimal extra risk associated with study assessments since most assessments are
also performed per standard care.
Additional "burden" is related to increased follow-up visits, x-ray at 12
months for subjects implanted with Investigational Product and all subjects are
asked to complete 3 (relative easy) questionnaire at FU visits.
150 Strafford Avenue #303
Wayne, PA 19087
US
150 Strafford Avenue #303
Wayne, PA 19087
US
Listed location countries
Age
Inclusion criteria
CLINICAL INCLUSION CRITERIA;1. * 18 years
3. Target limb requires no additional treatment aside from the target lesion and ipsilateral iliac artery
6. Rutherford Classification 2, 3 or 4
8. Eligible for standard surgical repair, if necessary
9. Subject is ambulatory (assistive devices such as a cane or walker is acceptable);ANGIOGRAPHIC INCLUSION CRITERIA;1. Reference vessel diameter is between 2.5 mm and 6.0 mm, inclusive (by visual estimate)
2. Ability to cross a guidewire (antegrade) through target lesion
3. Has a de novo or non-stented restenotic target lesion indicated for PTA treatment with a
standard or FDA-approved Lutonix drug-coated balloon catheter that meets the following
criteria below:
a. 70% to 99% stenosis with a total lesion length of *20mm and *150mm in length (by visual estimate) or
b.100% occluded with a total lesion length *100mm (by visual estimate)
c. A non-stented restenotic lesion must meet the following criteria:
i. Meets criteria 3a and 3b
ii. No part of the target lesion has been previously treated with a drugcoated
balloon
iii. No part of the target lesion has had more than 2 previous PTA failures
iv. >90 days from most recent angioplasty treatment
4.Target lesion is in the superficial femoral artery (SFA) and/or proximal popliteal artery (above the knee joint) defined as: located *1 cm below the common femoral artery (CFA) bifurcation to the distal segment of the proximal popliteal (P1) artery at the superior end of the patella
Exclusion criteria
CLINICAL EXCLUSION CRITERIA;1. Rutherford Classification 0, 1, 5 or 6
2. Is pregnant or refuses to use contraception through the duration of the study
3. Previous infrainguinal bypass graft in the target limb
8. Prior coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) procedure within 30 days prior to the index procedure or planned CABG/PCI within 30 days after the index procedure
9. Any other previous or planned surgical or endovascular procedure (not including
diagnostic procedures) within 14 days prior to or 30 days post index procedure
10. Planned atherectomy, cryoplasty, stenting or any other treatment (with the exception of a crossing device) of the target lesion other than PTA during the index procedure
16. Requires treatment of tibial or outflow vessels at the index procedure, which include the P2 and P3 segments of the popliteal artery and the tibioperoneal vessels.
18. Participating in another ongoing investigational clinical trial that has not completed its primary endpoint;ANGIOGRAPHIC EXCLUSION CRITERIA:;1. Retrograde access through target limb
2. Acute vessel occlusion or acute or sub-acute thrombosis in target lesion
3. Subject has significant stenosis (*50% stenosis) or occlusion of ipsilateral inflow iliac artery not successfully treated (<30% residual DS and without complication) prior to PTA of target vessel
4. Angiographic evidence of calcification severe enough that it renders the target lesion non-dilatable and/or has circumferential calcification
5. The target lesion shows no dissections after PTA
6. Presence of residual diameter stenosis *30% after PTA (based on visual estimate)
7. Non-target limb requiring any vascular treatment at time of index procedure
8. Previously implanted stent in the target vessel
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 |
|---|---|
| ClinicalTrials.gov | NCT02522884 |
| CCMO | NL55439.100.15 |