Clinical investigation of the Qmedics EXIST NiTi Stent type Flex & Pull in adults with Peripheral Artery Disease (PAD) (of the Q-medics NiTi Stent Family.
- Conditions
- Peripheral Artery Disease10003216
- Registration Number
- NL-OMON52001
- Lead Sponsor
- QMedics AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 50
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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method