Iliac Artery DiseaseNCT04822727
AndraTec PMCF Study : Investigating the AndraTec Guidewires,PTA Balloons and Stents in Iliac Disease.
An observational study of Iliac Artery Disease and Peripheral Artery Disease, run by Dr. Sabrina Overhagen.
Trial summary
This PMCF study is designed as prospective, multi-center study to collect real-life data. The rationale of this study is to confirm and support the clinical safety and performance of the aforementioned products in 200 patients who will undergo an endovascular intervention within standard-of-care (SOC) where at least 1… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iliac Artery Disease, Peripheral Artery Disease
- What is being tested?
- 1 or more AndraTec devices (see description for list of devices)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 31 Dec 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Patients with peripheral arterial disease, meeting the in/exclusion criteria and eligible for treatment with the AndraTec devices, according to the IFU of each device.
Who may be able to join
- Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.
- Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study (depending on the used device during the procedure) Patient is >18 years old Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study Patient is eligible for treatment with
- the Lokum L-Quest guidewire
- and/or the Lokum Amplatz guidewire
- and/or the Slider Hydrophilic Nitinol Guidewire
- and/or the AltoSa-XL PTA balloon
Show all 9Show fewer
- and/or the AltoSa-XL Gemini balloon catheter
- and/or the Optimus-XL CoCr Bare Metal Stent
- and/or the Optimus-XL CVS PTFE Covered Stent, as described in the IFU for each device.
Who cannot join
- Application in coronary, cerebral arteries and central circulatory system
- Known contraindication to peripheral arterial and visceral vasculature treatment - Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.
- Known contraindication and/or allergy to (a component of) an investigational device
- Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding
- Life expectancy of less than twelve months
- Any planned surgical intervention/procedure within 30 days of the study procedure
Show all 16Show fewer
- 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.
- Device-related exclusion criteria (not applicable for guidewire):
- Known contraindications given in the IFU of Optimus CoCr and Optimus-CVS PTFE- Covered Balloon-Expandable Stent which includes treatment of renal arteries, aneurysms adjacent to site of stent implantation and neurovascular treatment
- Known contraindications given in the IFU of AltoSa-XL-PTA and AltoSa-XL-Gemini Balloon catheter:
- patients with a contraindication for anti-platelet/anti-coagulant therapy
- patients with excessive vessel tortuosity
- dilatation of in-stent restenosis and highly calcified stenosis
- patients with perforated vessels evidenced by extravasation of contrast media
- patients with a known hypersensitivity to nylon
About this study
Official title: A Prospective Physician-Initiated PMCF Study Investigating the Safety and Clinical Performance of the Lokum L-Quest Guidewire, the Lokum Amplatz Guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA Balloon, the AltoSa-XL Gemini Balloon Catheter, the Optimus XL CoCr Stent and the Optimus CVS PTFE Covered XL Stent for the Endovascular Intervention
This PMCF study is designed as prospective, multi-center study to collect real-life data.
The rationale of this study is to confirm and support the clinical safety and performance of the aforementioned products in 200 patients who will undergo an endovascular intervention within standard-of-care (SOC) where at least 1 of the following devices from AndraTec were used:
The LOKUM-Quest guidewire, The LOKUM AMPLATZ guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA balloon, the AltoSa-XL GEMINI PTA Balloon, the OPTIMUS CoCr Stent , the OPTIMUS-CVS PTFE-Covered stent.
- Conditions
- Iliac Artery Disease, Peripheral Artery Disease
- Being tested
- 1 or more AndraTec devices (see description for list of devices)
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 or more AndraTec devices (see description for list of devices)Device
1 or more AndraTec devices (Lokum L-Quest guidewire, Lokum Amplatz guidewire, Slider Hydrophilic Nitinol Guidewire, AltoSa-XL PTA Balloon, Alto-Sa-XL Gemini Balloon, Optimus-CoCr stent, Optimus-CVS PTFE covered stent)
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from MACE (Major Adverse Clinical Events) and/or Device related events during the procedure
MACE defined as: Death, Myocardial Infarction, Stroke, Emergent surgical revascularization of the target vessel, repeat vascularization of the target vessel, bleeding complication requiring transfusion)
Measured: during procedure
Technical success rate
defined as successfully introduction and deployment of the Lokum L-Quest, and/or the Lokum Amplatz, and/or the Slider Hydrophilic Nitinol Guidewire, and/or the Optimus CoCr Stent, and/or the Optimus PFTE covered BE Stent, and/or the AltoSa-XL-PTA, and/or the AltoSa-XL-Gemini Balloon Catheter according to the respective IFU and without device related deficiencies.
Measured: during procedure
Secondary outcomes (3)
For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from MACE post-procedure, after 6- and 12-months.
MACE defined as: Death, Myocardial Infarction, Stroke, Emergent surgical revascularization of the target vessel, repeat vascularization of the target vessel, bleeding complication requiring transfusion)
Measured: Through study completion, an average of 1 year
For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from Device-related serious adverse events (SAE's) post-procedure, after 6- and 12-months
Freedom from Device-Related serious adverse events (SAE's)
Measured: Through study completion, an average of 1 year
Freedom from Target Lesion Revascularization post-procedure, at 6- and 12-months
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: Sponsor did not pusue with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iliac Artery 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Dr. Sabrina Overhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Sabrina Overhagen, FCRE (Foundation for Cardiovascular Research and Education)
- Investigators
- Giovanni Torsello, Prof. MD., Study director, Foundation for Cardiovascular Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822727
- Sponsor's protocol ID
- FCRE-201016
- Status last verified
- Aug 2023
- First submitted
- 24 Mar 2021
- Last updated
- 23 Aug 2023
- 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 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Physician-Initiated PMCF Study Investigating the Safety and Clinical Performance of the Lokum L-Quest Guidewire, the Lokum Amplatz Guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA Balloon, the AltoSa-XL Gemini Balloon Catheter, the Optimus XL CoCr Stent and the Optimus CVS PTFE Covered XL Stent for the Endovascular Intervention
- ClinicalTrials.gov ID
- NCT04822727
- Acronym / sponsor ID
- FCRE-201016
- Conditions
- Iliac Artery Disease, Peripheral Artery Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Sponsor did not pusue with the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dr. Sabrina OverhagenUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 30 Mar 2021 (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.
This PMCF study is designed as prospective, multi-center study to collect real-life data.
The rationale of this study is to confirm and support the clinical safety and performance of the aforementioned products in 200 patients who will undergo an endovascular intervention within standard-of-care (SOC) where at least 1 of the following devices from AndraTec were used:
The LOKUM-Quest guidewire, The LOKUM AMPLATZ guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA balloon, the AltoSa-XL GEMINI PTA Balloon, the OPTIMUS CoCr Stent , the OPTIMUS-CVS PTFE-Covered stent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peripheral arterial disease, meeting the in/exclusion criteria and eligible for treatment with the AndraTec devices, according to the IFU of each device.
Key inclusion criteria (9 listed)
- Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.
- Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study (depending on the used device during the procedure) Patient is >18 years old Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study Patient is eligible for treatment with
- the Lokum L-Quest guidewire
- and/or the Lokum Amplatz guidewire
- and/or the Slider Hydrophilic Nitinol Guidewire
Key exclusion criteria (16 listed)
- Application in coronary, cerebral arteries and central circulatory system
- Known contraindication to peripheral arterial and visceral vasculature treatment - Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.
- Known contraindication and/or allergy to (a component of) an investigational device
- Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding
- Life expectancy of less than twelve months
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 |
|---|---|---|
| 1 or more AndraTec devices (see description for list of devices)1 or more AndraTec devices (Lokum L-Quest guidewire, Lokum Amplatz guidewire, Slider Hydrophilic Nitinol Guidewire, AltoSa-XL PTA Balloon, Alto-Sa-XL Gemini Balloon, Optimus-CoCr stent, Optimus-CVS PTFE covered stent) | Device | – |
Primary outcome
Freedom from MACE (Major Adverse Clinical Events) and/or Device related events during the procedure
Time frame: during procedure
MACE defined as: Death, Myocardial Infarction, Stroke, Emergent surgical revascularization of the target vessel, repeat vascularization of the target vessel, bleeding complication requiring transfusion)
Technical success rate
Time frame: during procedure
defined as successfully introduction and deployment of the Lokum L-Quest, and/or the Lokum Amplatz, and/or the Slider Hydrophilic Nitinol Guidewire, and/or the Optimus CoCr Stent, and/or the Optimus PFTE covered BE Stent, and/or the AltoSa-XL-PTA, and/or the AltoSa-XL-Gemini Balloon Catheter according to the respective IFU and without device related deficiencies.
3 secondary outcomes
For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from MACE post-procedure, after 6- and 12-months.
Time frame: Through study completion, an average of 1 year
For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from Device-related serious adverse events (SAE's) post-procedure, after 6- and 12-months
Time frame: Through study completion, an average of 1 year
Freedom from Target Lesion Revascularization post-procedure, at 6- and 12-months
Time frame: Through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Iliac Artery Disease
Active, not recruitingObservational study
External Iliac Artery Endofibrosis in Cycling
Iliac Artery Occlusive Disease, Blood Flow Velocity
Active, not recruitingObservational study
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Peripheral Artery Disease, Popliteal Aneurysm
Recruiting
iHub Stent-Graft for Iliac Artery Aneurysms: Safety, Performance, and Effectiveness Study
Iliac Aneurysm, Aortic Aneurysm, Abdominal
RecruitingObservational study
Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study
Peripheral Arterial Disease, Aortoiliac Occlusive Disease
RecruitingObservational study
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)
Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD)
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.
Giovanni Torsello, Prof. MD. study director
Foundation for Cardiovascular Research and Education
Questions about this trial
What is this clinical trial studying?
An observational study of Iliac Artery Disease and Peripheral Artery Disease, run by Dr. Sabrina Overhagen.
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 9 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: withdrawn, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Freedom from MACE (Major Adverse Clinical Events) and/or Device related events during the procedure (time frame: during procedure). 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 23 Aug 2023.