The objective of the HORIZON trial is to demonstrate and provide long-term clinical data on safety and performance of the Qmedics EXIST NiTi Stent System type FLEX & PULL for treating de novo or re-stenotic symptomatic atherosclerotic lesions in…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary and secondary endpoints and additional endpoints will be evaluated
on an intent-to-treat
analysis and a per-treatment analysis. If a subject is enrolled, but a Qmedics
EXIST NiTi Stent type FLEX
or PULL is not implanted, the subject will not be followed through the
follow-up visits.
8.1 Primary Performance Endpoint
The primary patency rate is determined as primary performance endpoint (defined
as freedom from
more than >= 50% restenosis) at 6 - 12 months post-index procedure as measured
by PSVr at duplex
ultrasound (DUS). Peak systolic velocity ratio (PSVr) is calculated as peak
systolic velocity within the
area of the stenosis divided by peak systolic velocity in a normal adjacent
proximal artery segment. A
PSVr * 2,5 suggests a reduction in the luminal diameter >50%.
The primary safety endpoint is defined as the freedom from procedure- or
stent-related Major Adverse
Events (MAE*s) at 30-days post index-procedure. MAE is defined as all causes of
death and target limb
major amputation.
Secondary outcome
For the secondary endpoint following data will be collected:
Clinical success
1. Defined as improvement of Rutherford and Fontaine classification at 6- and
12-months follow-up of one class or more as compared to the pre-procedure and
an ankle-brachial index
improvement (ABI) by >= 0.15
Technical Succes:
2. To demonstrate that the Qmedics NiTi stent improves the primary patency with
>50% of
subjects with peripheral artery disease compared with literature data.
3. Stent fracture rate at 12- and 24-month follow-up. Evaluation at 12 and 24
months with x-ray.
Stent fracture is defined according to the following classification on x-ray:
Type 0: no structural fractures
Type I: single tine fracture
Type II: multiple tine fractures
Type III: stent fracture(s) with preserved alignment of the components
Type IV: stent fracture(s) with mal-alignment of the components
Type V: stent fracture(s) in a trans-axial spiral configurationHORIZON
Confidential
3. Walking Improvement at 30 days, 6, 12 and 24 months assessed by change in
Walking
Impairment Questionnaire (WIQ) from baseline
4. Measurement of the freedom of Target Lesion Revascularization (fTLR)
5. Patency rate and MAE at 24 months
Background summary
Large set of investigations have been conducted that demonstrating safety and
effectiveness for
devices from which components have been leveraged for the Qmedics NiTi Stent
System family.
Successful results have been seen so far demonstrate safety and effectiveness
for a variety of
indications in peripheral artery stenosis.
The overall rationale for this investigation is to provide long term clinical
data on safety and
performance of the Qmedics EXIST NiTi Stent System type Flex & Pull
Study objective
The objective of the HORIZON trial is to demonstrate and provide long-term
clinical data on safety and
performance of the Qmedics EXIST NiTi Stent System type FLEX & PULL for
treating de novo or re-stenotic symptomatic atherosclerotic lesions in
Peripheral Artery Disease (PAD) requiring treatment of the SFA or P1 segment,
and collect additional data including health economics data.
Study design
The HORIZON trial is a prospective, non-randomized, multi-center,
multi-national, clinical trial
conducted in several investigational sites in Europe.
Intervention
Placing of stent in periferal artery
Study burden and risks
Considering the nature and objective of the trial, being a Post-Market Clinical
Follow-up study with the
primary intention to collect additional data regarding the use of the Qmedics
Stent system type FLEX
& PULL, according to standard of care. The additional risk associated with
participating in this trial, is
related to the collection of patient data and confidentiality thereof.
The risks associated with the implantation of the Qmedics stent are described
in the current applicable
version of the IFU of the Qmedics stent system.
There may be additional risks linked to the procedure, and follow-up testing
which are unforeseen at
this time. All assessments planned for the follow-up period are standard of
care, apart from the quality
of life- and Walking Impairment questionnaires (QoL and WIQ), which do not
cause any additional risk
Winterthurerstrasse 1
Flurlingen 8247
CH
Winterthurerstrasse 1
Flurlingen 8247
CH
Listed location countries
Age
Inclusion criteria
Clinical:
1. Patient age 18 years or older
2. Subject is willing and able to provide consent before any study specific
test or procedure is
performed, signs the consent form, and agrees to attend all required follow-up
visits
3. Symptoms of peripheral arterial disease classified as Rutherford Category 2,
3 or 4 or Fontaine
Class IIb or III
4. The stenotic or occlusive lesion in SFA and P1 is considered suitable for
stenting
5. No underlying medical condition is present which would prevent the subject
from performing
the required testing or from completing the study.
6. stable medical condition
Anatomical criteria:
7. Included TASC II, A-B-C measured on pre- angio CT-scan (if CT-scan is
standard of care)
8. Lesions must be one or multiple that can be treated with maximum two stents,
maximum one
overlapping and maximum length of the stent 25 cm *
9. Patent ipsilateral iliac, popliteal (P2 and P3) and at least one tibial
vessel
Exclusion criteria
Subjects are excluded if ANY of the following criteria are met:
Clinical criteria:
1. Subjects pregnant, breastfeeding or planning to become pregnant during the
trial participation
2. Documented life expectancy less than 24 months due to other medical
co-morbid condition(s)
3. Thrombophlebitis or deep vein thrombosis within the past 30 days.
4. Impossibility in assuming DAPT
5. Concomitant renal failure with serum creatinine level > 2.5 mg/dL (or > 220
*mol/L) or
GFR < 30 ml/min/1,73 m2HORIZON Confidential
QME_HORIZON_CIP v1.0_01-oct-2019 page 15 of 52
6. Unresolved neutropenia (white blood cell count < 3,000 / µL) or
thrombocytopenia (platelet
count < 80,000 / µL) at the time of the index procedure
7. Unresolved bleeding disorder (INR >= 1.2) at the time of the index procedure
8. Active gastrointestinal bleeding
9. Anticoagulation therapy for other medical condition
Anatomical criteria:
10. Target lesion(s) received previous treatment within 30 days prior to
enrolment (point of
enrolment is defined as the time when the trial device enters the body)
11. Previously stented ipsilateral SFA
12. Prior peripheral vascular bypass surgery involving the target limb(s)
13. Target lesion is located within an aneurysm or associated with an aneurysm
in the vessel
segment either proximal or distal to the target lesion
14. Target lesion requires the use of cutting balloons, atherectomy or DCB
during the intervention
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 | NCT05234164 |
| CCMO | NL78634.078.21 |