Peripheral Arterial DiseaseBIO-OSCAR SOCNCT05831319
Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures
An observational study of Peripheral Arterial Disease, run by Biotronik AG at 17 sites in 8 countries.
Trial summary
Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 380 participants
- Where
- 17 sitesin 8 countries
- Study dates
- 29 May 2023to 30 Oct 2024
- 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: Subjects who have PAD with target lesion(s) located in the femoral, popliteal and/or infrapopliteal artery are eligible for the study. Up to 380 subjects will be enrolled in approximately 12 investigational sites in Europe.
Who may be able to join
- Subject ≥18 years old
- Subject has provided written informed consent
- Subject has Rutherford classification 2 to 6
- Reference vessel diameter ≥2 and ≤7 mm
- Target lesion(s) has stenosis >70% by visual assessment
- Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between the lesions will be considered one lesion.
Show all 13Show fewer
- For Above the knee (ATK) group
- Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
- At least 1 below-knee artery patent to the ankle
- Successful treatment of inflow iliac stenosis to the target lesion. Inflow lesion stenosis can be treated during the same procedure as per local standard of care.
- For Below the knee (BTK) group:
- Target lesions involve arteries below the tibial plateau
- Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion) resulting in ≤30% residual stenosis with no evidence of embolization or significant complications.
Who cannot join
- Subject has a single target lesion that involves both ATK and BTK segment.
- Subject not suitable for receiving endovascular procedures of lower limb arteries
- Prior planned major amputation in the target limb (above the ankle)
- Subject with previous bypass surgery of target vessel.
- History of any open surgical procedure within the past 30 days.
- Planned vascular surgery procedure within the next 30 days after the ATK and/or BTK procedure on the target limb. Note: The inflow vessels can be treated on the day of the procedure
Show all 10Show fewer
- Subject under dialysis
- Subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached
- Subject lacking capacity to provide informed consent
- Subject under judicial protection, tutorship, or curatorship (for France only)
Trial locations and contacts
17 sites in 8 countries.
17 sites in 8 countries
Belgium5 sites
OLV Ziekenhuis Aalst
Aalst
A.Z. Sint-Blasius
Dendermonde
Ziekenhuis Oost Limburg
Genk, Genk, 3600
University Hospital Ghent
Ghent, 9000
vzw AZ Groeninge
Kortrijk, 8500
Germany3 sites
Karolinen-Hospital, Klinikum Arnsberg
Arnsberg
Sank Gertrauden-Krankenhaus
Berlin
Universitätsklinikum Tübingen
Tübingen, Tübingen, 72076
Italy3 sites
Policlinico Abano Terme
Abano Terme, Abano Terme, 35031
Azienda Usl Toscana sud est
Arezzo, Arezzo, 52100
ospedaliero-universitaria Senese
Siena, 53100
Switzerland2 sites
Ospedale Regionale di Lugano
Lugano, Lugano, 6962
KS Winterthur
Winterthur
About this study
Official title: A Prospective, Multicenter, Observational Study Evaluating Standard of Care Practices, Procedural Outcomes, and In-hospital Complications of Endovascular Procedures for Treatment of Atherosclerotic Lesions in the Infrainguinal Arteries
Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.
Read the detailed description
The study will enroll consecutive eligible subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo and restenotic atherosclerotic lesions in femoral, popliteal and infrapopliteal arteries.
The purpose of this prospective, multicenter, observational European Study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications of endovascular peripheral interventions for treatment of lesions in the femoral, popliteal and infrapopliteal arteries.
- Conditions
- Peripheral Arterial Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Above the knee (ATK) group | Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau) | |
| Below the knee (BTK) group | Target lesions involve arteries below the tibial plateau |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success rate
Combination of technical success and absence of procedural complications
Measured: Index Procedure
Secondary outcomes (11)
Procedure technical success rate
successful crossing and achievement of a final residual diameter stenosis of ≤30% of the treated target lesion on the procedural completion angiography
Measured: Index Procedure
Rate of target lesion bailout stenting
Stented target lesion
Measured: Index Procedure
Stented length
Stented length
Measured: Index Procedure
Rate of PTA balloon related flow-limiting dissections
PTA balloon related flow-limiting dissections
Measured: Index Procedure
Rate of distal embolization
Distal embolization
Measured: Index Procedure
Rate of target vessel rupture
Target vessel rupture
Measured: Index Procedure
Rate of target vessel perforation
Target vessel perforation
Measured: Index Procedure
Rate of acute occlusion
Acute occlusion
Measured: Index Procedure
Primary crossing success rate
Successfully placement of a guidewire into the distal true lumen with the primary crossing strategy
Measured: Index Procedure
Rate of Serious Adverse Device Effects
Serious Adverse Device Effects
Measured: Index Procedure
Non-labor resource use
Devices use
Measured: Index procedure until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start29 May 2023
- Primary completion1 Jun 2024
- Study completion30 Oct 2024
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deloose Koen, Dr, Study chair, AZ Saint Blasius, Dendermonde, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831319
- Sponsor's protocol ID
- C2201
- Acronym
- BIO-OSCAR SOC
- Status last verified
- Feb 2024
- First submitted
- 14 Apr 2023
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data (IPD) is not yet drafted. No decision is taken to share it yet.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Study Evaluating Standard of Care Practices, Procedural Outcomes, and In-hospital Complications of Endovascular Procedures for Treatment of Atherosclerotic Lesions in the Infrainguinal Arteries
- ClinicalTrials.gov ID
- NCT05831319
- Acronym / sponsor ID
- BIO-OSCAR SOC / C2201
- Conditions
- Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- 29 May 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 26 Apr 2023 (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.
Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.
Detailed description
The study will enroll consecutive eligible subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo and restenotic atherosclerotic lesions in femoral, popliteal and infrapopliteal arteries.
The purpose of this prospective, multicenter, observational European Study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications of endovascular peripheral interventions for treatment of lesions in the femoral, popliteal and infrapopliteal arteries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Above the knee (ATK) group | – | –Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau) |
| Below the knee (BTK) group | – | –Target lesions involve arteries below the tibial plateau |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have PAD with target lesion(s) located in the femoral, popliteal and/or infrapopliteal artery are eligible for the study. Up to 380 subjects will be enrolled in approximately 12 investigational sites in Europe.
Key inclusion criteria (13 listed)
- Subject ≥18 years old
- Subject has provided written informed consent
- Subject has Rutherford classification 2 to 6
- Reference vessel diameter ≥2 and ≤7 mm
- Target lesion(s) has stenosis >70% by visual assessment
Key exclusion criteria (10 listed)
- Subject has a single target lesion that involves both ATK and BTK segment.
- Subject not suitable for receiving endovascular procedures of lower limb arteries
- Prior planned major amputation in the target limb (above the ankle)
- Subject with previous bypass surgery of target vessel.
- History of any open surgical procedure within the past 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procedural success rate
Time frame: Index Procedure
Combination of technical success and absence of procedural complications
11 secondary outcomes
Procedure technical success rate
Time frame: Index Procedure
Rate of target lesion bailout stenting
Time frame: Index Procedure
Stented length
Time frame: Index Procedure
Rate of PTA balloon related flow-limiting dissections
Time frame: Index Procedure
Rate of distal embolization
Time frame: Index Procedure
Rate of target vessel rupture
Time frame: Index Procedure
Rate of target vessel perforation
Time frame: Index Procedure
Rate of acute occlusion
Time frame: Index Procedure
Primary crossing success rate
Time frame: Index Procedure
Rate of Serious Adverse Device Effects
Time frame: Index Procedure
Non-labor resource use
Time frame: Index procedure until discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Undecided. The individual participant data (IPD) is not yet drafted. No decision is taken to share it yet.
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Deloose Koen, Dr study chair
AZ Saint Blasius, Dendermonde, Belgium
17 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Biotronik AG at 17 sites in 8 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 13 inclusion and 10 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: finished, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Belgium, Germany, Italy, Switzerland, Austria and 3 more countries. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Procedural success rate (time frame: Index 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 1 Nov 2024.