The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the Solaris Vascular Stent Graft (Scitech) in clinical settingswhen used according to the indications of the…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study is primary patency at 12 months , defined as
a target lesion without a hemodynamically significant stenosis on duplex
ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without
Target Lesion Revascularization (TLR) within 12 months.
Secondary outcome
1.Primary patency rate at 1- and 6-month follow-up. Patients that present
without a hemodynamically significant stenosis at the target area on duplex
ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without
prior TLR are defined as being primary patent at the given follow-up.
2. Stent graft occlusion rate at pre-discharge, 1-, 6- and 12-month follow-up.
3. Ankle Brachial Index (ABI) at 1-, 6- and 12-month follow-up compared with
the baseline ABI.
4. Amputation rate at 1-, 6- and 12-month follow-up, defined as any amputation
above the knee.
5. Performance success rate at baseline, defined as a composite of:
a. successful in sealing acute perforation or rupture
b. successful in treating aneurysms and fistulae
c. restoration of blood flow
6. In-stent restenosis rate
7. Freedom from Target Lesion Revascularization (TLR), defined as freedom from
a repeat intervention to maintain or re-establish patency within the region of
the treated arterial vessel plus 5mm proximal and distal to the treated lesion
edge.
8. Serious Adverse Events (SAEs), defined according to ISO 14155:2020 as any
clinical event that is fatal, life-threatening, or judged to be severe by the
investigator; resulted in persistent or significant disability; necessitated
surgical or percutaneous intervention; or required prolonged hospitalization.
9. Technical success, defined as the ability to achieve final residual
angiographic stenosis no greater than 30%.
10. Clinical success at follow-up is defined as an improvement of Rutherford
classification at 1-, 6- and 12-month follow-up of one class or more as
compared to the pre-procedure Rutherford classification.
Background summary
Helping patients with peripheral arterial disease in the iliac arteries
Study objective
The objective of this clinical investigation is to evaluate, in a controlled
setting, the long-term (up to 12 months) safety and efficacy of the Solaris
Vascular Stent Graft (Scitech) in clinical settings
when used according to the indications of the IFU.
Study design
Prospective, multi-center, controlled physician-sponsored clinical study
Study burden and risks
not applicable. everything according to standard of care (treatment and
follow-up schedule)
Plaggenbahn 6
Bottrop 46242
DE
Plaggenbahn 6
Bottrop 46242
DE
Listed location countries
Age
Inclusion criteria
Patient presenting with a stenotic or occlusive lesion at the iliac arteries
suitable for stenting
Patient presenting with a score from 2 to 5 following Rutherford Classification
Patient is willing to comply with specified follow-up evaluations at the
specified times for the duration of the study
Patient is >18 years old
Patient (or their legal representative) understands the nature of the procedure
and provides written informed consent, prior to enrolment in the study
Patient is eligible for treatment with the SOLARIS® Vascular Stent Graft
(Scitech Medical)
Exclusion criteria
PTA is technically not possible (not feasible to access the lesion or a defect
with the guidewire or balloon catheter)
Presence of an aneurysm immediately adjacent to the site of stent implantation
Stenosis distal to the site of stent implantation
Lesions in or adjacent to essential collaterals(s)
Lesions in locations subject to external compression
Heavily calcified lesions resistant to PTA
Patients with diffuse distal disease resulting in poor stent outflow
Patients with a history of coagulation disorders
Patients with aspirin allergy or bleeding complications and patients unable or
unwilling to tolerate anticoagulant/antiplatelet therapy and/or non-responders
to anticoagulant/antiplatelet therapy
Fresh thrombus formation
Patients with known hypersensitivity to the stent material (L605) and/or PTFE
Previously implanted stent(s) at the same lesion site
Reference segment diameter is not suitable for the available stent design
Untreatable lesion located at the distal outflow arteries
Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation
therapy) as part of the index procedure
Patients refusing treatment
Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs
are contraindicated
- Patients who exhibit persistent acute intraluminal thrombus of the proposed
lesion site
- Perforation at the angioplasty site evidenced by extravasation of contrast
medium
- Patients with a history of prior life-threatening contrast medium reaction
- Patients with uncorrected bleeding disorders
- Female patient with childbearing potential not taking adequate contraceptives
- Life expectancy of less than twelve months
- Any planned surgical intervention/procedure within 30 days of the study
procedure
- Any patient considered to be hemodynamically unstable at onset of procedure
- Patient is currently participating in another investigational drug or device
study that has not
completed the entire follow up period.
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 | NCT04299906 |
| CCMO | NL75935.100.20 |