- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05234164
HORIZON Prospective Clinical Investigation
February 13, 2024 updated by: Qmedics AG
HORIZON. Clinical Investigation of the Qmedics EXIST NiTi Stent Type FLEX & PULL in Adults With Peripheral Artery Disease (PAD)
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 investigation for the treatment of adult patients with de novo or re-stenotic symptomatic atherosclerotic lesions in Peripheral Artery Disease (PAD) requiring treatment of the Superficial Femoral Artery (SFA) or Proximal Popliteal Artery (P1 segment).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 receive the FLEX type and 115 subjects the PULL type) in several centers, minimum 10 patients per investigational center.
All patients will be evaluated at 30 days and 6-, 12- and 24-months post-index procedure.
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Oana Brancati, PhD
- Phone Number: + 41 44 515 82 26
- Email: oana.brancati@qmedics.ch
Study Contact Backup
- Name: Anita Patteet, MD
- Phone Number: + 41 44 515 82 20
- Email: anita.patteet@qmedics.ch
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EXIST 6F NiTi Stent System FLEX
Stent implantation of lesions in the SFA graded with Fanelli 1 and 2, and lesions in the P1 segment of the proximal popliteal artery.
|
Subjects requiring treatment of the P1 segment of the proximal popliteal artery will be treated with the Exist 6F NiTi Stent FLEX type.
Subjects requiring treatment of the SFA will undergo an additional calcification review based on the Fanelli classification.
Subjects graded with Fanelli 1 or 2 will be treated with the Exist 6F NiTi Stent FLEX type.
|
Experimental: EXIST 6F NiTi Stent System PULL
Stent implantation of lesions in the SFA graded with 3 and 4.
|
Subjects requiring treatment of the SFA will undergo a calcification review based on the Fanelli classification.
Subjects graded with Fanelli grade 3 and 4 will be treated with the Exist 6F NiTi Stent PULL type.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary patency
Time Frame: 12 months
|
The primary patency rate (defined as freedom from more than ≥ 50% restenosis) at 12 months post-procedure as measured by Peak Systolic Velocity ratio (PSVr) assessed with Duplex ultrasound (DUS).
A PSVr ≥ 2,5 suggests a reduction in the luminal diameter >50%.
|
12 months
|
Major Adverse Events
Time Frame: 1 month
|
Freedom from procedure- or stent-related Major Adverse Events (MAEs) at 30-days post index-procedure will be reported.
MAE is defined as all causes of death and target limb major amputation, defined as amputation of the lower limb at the ankle level or above.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of Rutherford / Fontaine classification
Time Frame: 6- and 12-months
|
Clinical success Defined as improvement of Rutherford / Fontaine classification of one class or more as compared to the pre-procedure and an ankle-brachial index improvement (ABI) by ≥ 0.15.
|
6- and 12-months
|
Primary patency
Time Frame: 12-months
|
Compare the Exist 6F NiTi stent primary patency with >50% of subjects with peripheral artery disease with literature data.
|
12-months
|
Rate of stent fracture
Time Frame: 12- and 24-months
|
Stent fracture rate is evaluated with x-ray.
Stent fracture is defined according to classification on x-ray.
|
12- and 24-months
|
Freedom from Target Lesion Revascularization
Time Frame: 1 month, 6-, 12- and 24-months
|
Defined as the absence of revascularization (by any means) of the target lesion (fTLR).
|
1 month, 6-, 12- and 24-months
|
Walking and mobility
Time Frame: 1 month, 6-, 12- and 24-months
|
Improvement of walking and mobility is assessed by change in the 36-Item Short Form Survey (SF-36) score from baseline.
|
1 month, 6-, 12- and 24-months
|
Patency rate
Time Frame: 24 months
|
Patency rate as measured by Peak Systolic Velocity ratio (PSVr) assessed with Duplex ultrasound (DUS).
A PSVr ≥ 2,5 suggests a reduction in the luminal diameter >50%.
|
24 months
|
Major Adverse Events
Time Frame: 24 months
|
Procedure- or stent-related Major Adverse Events (MAEs) post index-procedure will be reported.
MAE is defined as all causes of death and target limb major amputation, defined as amputation of the lower limb at the ankle level or above.
|
24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported Quality of life
Time Frame: 1 month, 6-, 12- and 24-months
|
Improvement of quality of life is assessed by change in the 36-Item Short Form Survey (SF-36) score from baseline.
|
1 month, 6-, 12- and 24-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Anita Patteet, MD, Qmedics AG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 15, 2021
Primary Completion (Actual)
November 17, 2023
Study Completion (Actual)
November 17, 2023
Study Registration Dates
First Submitted
January 31, 2022
First Submitted That Met QC Criteria
January 31, 2022
First Posted (Actual)
February 10, 2022
Study Record Updates
Last Update Posted (Actual)
February 14, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 120884
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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