Peripheral Arterial DiseaseNCT05234164
HORIZON Prospective Clinical Investigation
A study testing EXIST 6F NiTi Stent System FLEX and EXIST 6F NiTi Stent System PULL in people with Peripheral Arterial Disease, run by Qmedics AG at 2 sites in 2 countries.
Trial 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 investigation for the treatment of adult patients with de novo or re-stenotic symptomatic atherosclerotic lesions in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- EXIST 6F NiTi Stent System FLEX and EXIST 6F NiTi Stent System PULL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Dec 2021to 17 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Poland1 site
University Clinical Hospital of Bialystok
Bialystok, Podlaskie Voivodeship, 15-276
About this study
Official title: 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).
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- EXIST 6F NiTi Stent System FLEX, EXIST 6F NiTi Stent System PULL
- Keywords
- stenotic lesions, Peripheral Arterial Disease, occluded lesions, Superficial Femoral Artery, nitinol stent, self-expanding stent, Chronic Limb-Threatening Ischemia
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXIST 6F NiTi Stent System FLEXDevice
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.
EXIST 6F NiTi Stent System PULLDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EXIST 6F NiTi Stent System FLEX | Experimental | Stent implantation of lesions in the SFA graded with Fanelli 1 and 2, and lesions in the P1 segment of the proximal popliteal artery. Receives: Device: EXIST 6F NiTi Stent System FLEX |
| EXIST 6F NiTi Stent System PULL | Experimental | Stent implantation of lesions in the SFA graded with 3 and 4. Receives: Device: EXIST 6F NiTi Stent System PULL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
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%.
Measured: 12 months
Major Adverse Events
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.
Measured: 1 month
Secondary outcomes (7)
Improvement of Rutherford / Fontaine classification
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.
Measured: 6- and 12-months
Primary patency
Compare the Exist 6F NiTi stent primary patency with >50% of subjects with peripheral artery disease with literature data.
Measured: 12-months
Rate of stent fracture
Stent fracture rate is evaluated with x-ray. Stent fracture is defined according to classification on x-ray.
Measured: 12- and 24-months
Freedom from Target Lesion Revascularization
Defined as the absence of revascularization (by any means) of the target lesion (fTLR).
Measured: 1 month, 6-, 12- and 24-months
Walking and mobility
Improvement of walking and mobility is assessed by change in the 36-Item Short Form Survey (SF-36) score from baseline.
Measured: 1 month, 6-, 12- and 24-months
Patency rate
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%.
Measured: 24 months
Major Adverse Events
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start15 Dec 2021
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subjects requiring treatment of the SFA will undergo a calcification review based on the Fanelli classification. Subjects graded with Fanelli 1 or 2, and subjects requiring treatment of the P1 segment of the proximal popliteal artery will be treated with the Exist 6F NiTi Stent type FLEX. Subject graded with Fanelli 3 and 4 will be treated with the Exist 6F NiTi Stent PULL.
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qmedics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Policlinico di Monza, University Clinical Hospital of Bialystok, University Hospital, Catania, Erasmus Medical Center, University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Anita Patteet, MD, Study director, Qmedics AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234164
- Sponsor's protocol ID
- 120884
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2022
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HORIZON. Clinical Investigation of the Qmedics EXIST NiTi Stent Type FLEX & PULL in Adults With Peripheral Artery Disease (PAD)
- ClinicalTrials.gov ID
- NCT05234164
- Acronym / sponsor ID
- 120884
- Conditions
- Peripheral Arterial Disease
- Keywords
- stenotic lesions, Peripheral Arterial Disease, occluded lesions, Superficial Femoral Artery, nitinol stent, self-expanding stent, Chronic Limb-Threatening Ischemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Qmedics AGIndustry (pharma, biotech, devices)
- Collaborators
- Policlinico di Monza, University Clinical Hospital of Bialystok, University Hospital, Catania, Erasmus Medical Center, University Hospital, Geneva
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects requiring treatment of the SFA will undergo a calcification review based on the Fanelli classification. Subjects graded with Fanelli 1 or 2, and subjects requiring treatment of the P1 segment of the proximal popliteal artery will be treated with the Exist 6F NiTi Stent type FLEX. Subject graded with Fanelli 3 and 4 will be treated with the Exist 6F NiTi Stent PULL.
| Arm | Type | Receives |
|---|---|---|
| EXIST 6F NiTi Stent System FLEX | Experimental | Device: EXIST 6F NiTi Stent System FLEXStent implantation of lesions in the SFA graded with Fanelli 1 and 2, and lesions in the P1 segment of the proximal popliteal artery. |
| EXIST 6F NiTi Stent System PULL | Experimental | Device: EXIST 6F NiTi Stent System PULLStent implantation of lesions in the SFA graded with 3 and 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXIST 6F NiTi Stent System FLEXSubjects 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. | Device | EXIST 6F NiTi Stent System FLEX |
| EXIST 6F NiTi Stent System PULLSubjects 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. | Device | EXIST 6F NiTi Stent System PULL |
Primary outcome
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%.
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.
7 secondary outcomes
Improvement of Rutherford / Fontaine classification
Time frame: 6- and 12-months
Primary patency
Time frame: 12-months
Rate of stent fracture
Time frame: 12- and 24-months
Freedom from Target Lesion Revascularization
Time frame: 1 month, 6-, 12- and 24-months
Walking and mobility
Time frame: 1 month, 6-, 12- and 24-months
Patency rate
Time frame: 24 months
Major Adverse Events
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Business decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Patteet, MD study director
Qmedics AG
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXIST 6F NiTi Stent System FLEX and EXIST 6F NiTi Stent System PULL in people with Peripheral Arterial Disease, run by Qmedics AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.