Status:
TERMINATED
HORIZON Prospective Clinical Investigation
Lead Sponsor:
Qmedics AG
Collaborating Sponsors:
Policlinico di Monza
University Clinical Hospital of Bialystok
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX \& PULL in a prospective invest...
Detailed Description
This is a multicenter, prospective study with clinical and radiographic follow-up for 24 months months post-procedure. Approximately two hundred thirty subjects will be enrolled (115 subjects will rec...
Eligibility Criteria
Inclusion
- \- Clinical:
- Patient age 18 years or older
- 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
- Symptoms of peripheral arterial disease classified as Rutherford Category 2, 3 or 4 or Fontaine Class IIb or III
- The stenotic or occlusive lesion in Superficial Femoral Artery (SFA) and proximal popliteal artery, P1 segment, is considered suitable for stenting
- No underlying medical condition is present which would prevent the subject from performing the required testing or from completing the study.
- Stable medical condition
- Anatomical criteria:
- Included TASC II, A-B-C measured on pre- angio CT-scan (if CT-scan is standard of care)
- 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
- Patent ipsilateral iliac, popliteal (P2 and P3) and at least one tibial vessel
Exclusion
- \- Clinical criteria:
- Subjects pregnant, breastfeeding or planning to become pregnant during the trial participation
- Documented life expectancy less than 24 months due to other medical co-morbid condition(s)
- Thrombophlebitis or deep vein thrombosis within the past 30 days.
- Unable to assume DAPT (Dual Antiplatelet Therapy)
- Concomitant renal failure with serum creatinine level \> 2.5 mg/dL (or \> 220 µmol/L) or GFR \< 30 ml/min/1,73 m2
- Unresolved neutropenia (white blood cell count \< 3,000 / µL) or thrombocytopenia (platelet count \< 80,000 / µL) at the time of the index procedure
- Unresolved bleeding disorder (INR ≥ 1.2) at the time of the index procedure
- Active gastrointestinal bleeding
- Anticoagulation therapy for other medical condition
- Anatomical criteria:
- 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)
- Previously stented ipsilateral SFA
- Prior peripheral vascular bypass surgery involving the target limb(s)
- Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion
- Target lesion requires the use of cutting balloons, atherectomy or drug coated balloons (DCB) during the intervention
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2023
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT05234164
Start Date
December 15 2021
End Date
November 17 2023
Last Update
February 14 2024
Active Locations (2)
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1
University Hospital of Catania
Catania, Sicily, Italy, 95123
2
University Clinical Hospital of Bialystok
Bialystok, Podlaskie Voivodeship, Poland, 15-276