Femoropopliteal StenosisOptimoNCT05057637
The Impact of Optical Coherence Tomography on the Endovascular Treatment Planning of Femoropopliteal Disease
An observational study of Femoropopliteal Stenosis, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Rationale: Peripheral arterial disease is a severe clinical problem with an increasing prevalence, due to an ageing population. Endovascular treatment, usually using stents, is recommended for most lesions in the femoropopliteal tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoropopliteal Stenosis
- What is being tested?
- Optical coherence tomography measurements
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Mar 2022to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 diagnosed with one or more stenotic lesions in the femoropopliteal tract that are scheduled for endovascular treatment with a Supera interwoven nitonol stent or Absolute nitinol stent.
Who may be able to join
- Aged 18 years of older
- Written informed consent
- Scheduled endovascular treatment of femoropopliteal stenotic lesions with a Supera interwoven nitinol stent or Absolute nitinol stent
- Clinically and hemodynamically stable
Who cannot join
- Occluded superficial femoral artery or popliteal artery
- Superficial femoral artery and/or popliteal artery diameter larger than 6.5 mm
- Severely impaired renal function (eGFR < 30 ml/min), end stage renal disease
- Cardiac insufficiency (NYHA 3-4)
- Hypersensitivity to iodinated contrast media
- BMI > 25 and contralateral approach not possible
Show all 12Show fewer
- Minimal lumen diameter of target lesion < 1.5 mm
- Presence of a hemodynamically significant inflow stenosis in the aorto-iliac tract or the common femoral artery
- Participating in another trial with an investigational drug or medical device concerning the femoropopliteal tract interfering with the current study
- Life expectancy of less than 24 months
- Women of child-bearing age not on active birth control
- Legally incapable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Optical Coherence Tomography on the Decision-making Process of Endovascular Treatment of Femoropopliteal Disease
Rationale: Peripheral arterial disease is a severe clinical problem with an increasing prevalence, due to an ageing population. Endovascular treatment, usually using stents, is recommended for most lesions in the femoropopliteal tract. The patency of these stents is influenced by several factors, including stent sizing and stent positioning.
Current procedural planning of femoropopliteal disease is primarily based on single-plane digital subtraction angiographies (DSA). This modality provides a 2-dimensional image of the vessel lumen, which may be suboptimal for stent sizing. It can therefore be difficult to choose the optimal stent position as minor lesions may be missed. Suboptimal treatment could result in unfavourable levels of wall shear stress causing the vessel wall to be more susceptible to neo-intimal hyperplasia ultimately causing restenosis and stent failure. Intravascular optical coherence tomography (OCT) is able to visualize the arterial wall with a micrometer resolution, which could result in better stent sizing. Furthermore, OCT is able to visualize different layers in the vessel wall and identify unhealthy areas, which may lead to a more optimal stent placement as unhealthy areas can be covered completely. Moreover, OCT provides detailed patient-specific geometries necessary to develop reliable computational fluid dynamics (CFD) models that simulate blood flow in stented arteries and calculate wall shear stresses, which could predict stent patency.
Read more
Objective: To investigate in a clinical study how often the use of intravascular optical coherence tomography for femoropopliteal stenotic lesions leads to alterations in treatment planning before and after stent placement, in comparison to traditional digital subtraction angiography-based treatment planning.
Study design: Exploratory observational study. Study population: 25 patients with femoropopliteal stenotic lesions who are treated with a Supera interwoven nitinol stent or Absolute nitinol stent.
Main study parameters/endpoints: The percentage of procedures in which OCT changed the DSA-based treatment planning before and after stent placement to investigate the impact of OCT imaging on treatment planning.
- Conditions
- Femoropopliteal Stenosis
- Being tested
- Optical coherence tomography measurements
- Keywords
- optical coherence tomography, digital subtraction angiography, endovascular treatment planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography measurementsDevice
Also called Ilumien Optis
Optical coherence tomography measurements in femoropopliteal tract
| Study group | Role | What they receive |
|---|---|---|
| Complete cohort | In all patients included in the study subsequent optical coherence tomography (OCT) measurements will be performed pre and post stent placement. Receives: Device: Optical coherence tomography measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed treatment planning based on OCT
The percentage of procedures in which the OCT changed the DSA-based treatment planning before and after stent placement to investigate the impact of OCT imaging on treatment planning.
Measured: Immediately following the procedure
Secondary outcomes (12)
Presence of artefacts in CTA scan
The presence of artefacts will be used to determine the image quality of the CTA scan
Measured: 6-8 weeks after the procedure
Presence of artefacts in OCT scan
The presence of artefacts will be used to determine the image quality of the OCT scan
Measured: Immediately following the procedure
Segmented vessel lumen based on CTA scan
The vessel lumen in the CTA scan will be segmented to obtain a patient-specific geometry.
Measured: Up to 2 years after the procedure
Segmented vessel lumen based on OCT scan
The vessel lumen in the OCT scan will be segmented to obtain a patient-specific geometry.
Measured: Up to 2 years after the procedure
Correlation CTA-based and OCT-based vessel lumen segmentations
The obtained CTA-based segmentation will be compared to the OCT-based segmentation. The vessel radius along the blood vessel for both the CTA-based and OCT-based segmentation will be compared point-by-point after which the correlation beteen both segmentations will be obtained
Measured: Up to 2 years after the procedure
Velocity streamlines obtained from CTA-based CFD simulation
Velocity streamlines are calculated using a computational fluid dynamics model based on the CTA-based vessel lumen segmentation.
Measured: Up to 2 years after the procedure
Time averaged wall shear stress obtained from CTA-based CFD simulation
The second parameter calculated using the CTA-based CFD simulation is the time averaged wall shear stress. This is the wall shear stress averagerd over one heartbeat.
Measured: Up to 2 years after the procedure
Velocity streamlines obtained from OCT-based CFD simulation
Velocity streamlines are calculated using a computational fluid dynamics model based on the OCT-based vessel lumen segmentation.
Measured: Up to 2 years after the procedure
Time averaged wall shear stress obtained from OCT-based CFD simulation
The second parameter calculated using the OCT-based CFD simulation is the time averaged wall shear stress. This is the wall shear stress averagerd over one heartbeat.
Measured: Up to 2 years after the procedure
Late luminal loss
Defined as the vessel diameter right after procedure minus the vessel diameter during follow-up
Measured: Up to 2 years after the procedure
Correlation between late luminal loss and CTA-based CFD
The regions with late luminal loss will be compared to regions with disturbed velocity streamlines and low time averaged wall shear stress (<0.4 Pa) calculated with the CTA-based CFD. This correlation shows how well the CTA-based CFD model can predict late luminal loss.
Measured: Up to 2 years after the procedure
Correlation between late luminal loss and OCT-based CFD
The regions with late luminal loss will be compared to regions with disturbed velocity streamlines and low time averaged wall shear stress (<0.4 Pa) calculated with the OCT-based CFD. This correlation shows how well the OCT-based CFD model can predict late luminal loss.
Measured: Up to 2 years after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start9 Mar 2022
- Primary completion12 Dec 2025
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal StenosisStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente, Abbott
- Responsible party
- Sponsor
- Investigators
- Michel Reijnen, MD, prof, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057637
- Sponsor's protocol ID
- Optimo study
- Acronym
- Optimo
- Status last verified
- Jan 2026
- First submitted
- 1 Sep 2021
- Last updated
- 7 Jan 2026
- 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Optical Coherence Tomography on the Decision-making Process of Endovascular Treatment of Femoropopliteal Disease
- ClinicalTrials.gov ID
- NCT05057637
- Acronym / sponsor ID
- Optimo / Optimo study
- Conditions
- Femoropopliteal Stenosis
- Keywords
- optical coherence tomography, digital subtraction angiography, endovascular treatment planning
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- University of Twente, Abbott
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Sep 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.
Rationale: Peripheral arterial disease is a severe clinical problem with an increasing prevalence, due to an ageing population. Endovascular treatment, usually using stents, is recommended for most lesions in the femoropopliteal tract. The patency of these stents is influenced by several factors, including stent sizing and stent positioning.
Current procedural planning of femoropopliteal disease is primarily based on single-plane digital subtraction angiographies (DSA). This modality provides a 2-dimensional image of the vessel lumen, which may be suboptimal for stent sizing. It can therefore be difficult to choose the optimal stent position as minor lesions may be missed. Suboptimal treatment could result in unfavourable levels of wall shear stress causing the vessel wall to be more susceptible to neo-intimal hyperplasia ultimately causing restenosis and stent failure. Intravascular optical coherence tomography (OCT) is able to visualize the arterial wall with a micrometer resolution, which could result in better stent sizing. Furthermore, OCT is able to visualize different layers in the vessel wall and identify unhealthy areas, which may lead to a more optimal stent placement as unhealthy areas can be covered completely. Moreover, OCT provides detailed patient-specific geometries necessary to develop reliable computational fluid dynamics (CFD) models that simulate blood flow in stented arteries and calculate wall shear stresses, which could predict stent patency.
Objective: To investigate in a clinical study how often the use of intravascular optical coherence tomography for femoropopliteal stenotic lesions leads to alterations in treatment planning before and after stent placement, in comparison to traditional digital subtraction angiography-based treatment planning.
Study design: Exploratory observational study. Study population: 25 patients with femoropopliteal stenotic lesions who are treated with a Supera interwoven nitinol stent or Absolute nitinol stent.
Main study parameters/endpoints: The percentage of procedures in which OCT changed the DSA-based treatment planning before and after stent placement to investigate the impact of OCT imaging on treatment planning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Complete cohort | – | Device: Optical coherence tomography measurementsIn all patients included in the study subsequent optical coherence tomography (OCT) measurements will be performed pre and post stent placement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with one or more stenotic lesions in the femoropopliteal tract that are scheduled for endovascular treatment with a Supera interwoven nitonol stent or Absolute nitinol stent.
Key inclusion criteria (4 listed)
- Aged 18 years of older
- Written informed consent
- Scheduled endovascular treatment of femoropopliteal stenotic lesions with a Supera interwoven nitinol stent or Absolute nitinol stent
- Clinically and hemodynamically stable
Key exclusion criteria (12 listed)
- Occluded superficial femoral artery or popliteal artery
- Superficial femoral artery and/or popliteal artery diameter larger than 6.5 mm
- Severely impaired renal function (eGFR < 30 ml/min), end stage renal disease
- Cardiac insufficiency (NYHA 3-4)
- Hypersensitivity to iodinated contrast media
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 |
|---|---|---|
| Optical coherence tomography measurementsAlso: Ilumien OptisOptical coherence tomography measurements in femoropopliteal tract | Device | Complete cohort |
Primary outcome
Changed treatment planning based on OCT
Time frame: Immediately following the procedure
The percentage of procedures in which the OCT changed the DSA-based treatment planning before and after stent placement to investigate the impact of OCT imaging on treatment planning.
12 secondary outcomes
Presence of artefacts in CTA scan
Time frame: 6-8 weeks after the procedure
Presence of artefacts in OCT scan
Time frame: Immediately following the procedure
Segmented vessel lumen based on CTA scan
Time frame: Up to 2 years after the procedure
Segmented vessel lumen based on OCT scan
Time frame: Up to 2 years after the procedure
Correlation CTA-based and OCT-based vessel lumen segmentations
Time frame: Up to 2 years after the procedure
Velocity streamlines obtained from CTA-based CFD simulation
Time frame: Up to 2 years after the procedure
Time averaged wall shear stress obtained from CTA-based CFD simulation
Time frame: Up to 2 years after the procedure
Velocity streamlines obtained from OCT-based CFD simulation
Time frame: Up to 2 years after the procedure
Time averaged wall shear stress obtained from OCT-based CFD simulation
Time frame: Up to 2 years after the procedure
Late luminal loss
Time frame: Up to 2 years after the procedure
Correlation between late luminal loss and CTA-based CFD
Time frame: Up to 2 years after the procedure
Correlation between late luminal loss and OCT-based CFD
Time frame: Up to 2 years after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- 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.
Michel Reijnen, MD, prof principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoropopliteal Stenosis, run by Rijnstate Hospital at 1 site in Netherlands.
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 4 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changed treatment planning based on OCT (time frame: Immediately following the procedure). 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 7 Jan 2026.