Peripheral Arterial DiseaseNCT05312580
PMCF Study for Peripheral Arteries Above the Knee (ATK)
An observational study of Peripheral Arterial Disease and Femoropopliteal Stenosis, run by Cordis US Corp. at 9 sites in 3 countries.
Trial summary
The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least 1 of the products (named above) from Cordis US… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Femoropopliteal Stenosis, Angiopathy, Peripheral
- How many people
- 387 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 1 Jun 2022to 7 Nov 2022
- 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: Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with at least one of the above mentioned study devices.
Who may be able to join
- Patient is >18 years old at conduction of the procedure.
- Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with at least one of the following the S.M.A.R.T. Flex Stent Iliac and/or S.M.A.R.T. Flex SFA/PP and/or S.M.A.R.T. Control Nitinol Stent and/or S.M.A.R.T. Nitinol Stent and/or PALMAZ Blue .018 Peripheral Stent on Slalom and/or PALMAZ Genesis .035 Peripheral Stent on Opta Pro and/or SABER OTW PTA Catheter and/or SABERX PTA Dilatation Catheter and/or PowerFlex Pro PTA Catheter as described in the IFU of the devices.
- Target Lesion is located in the ilio-femoropopliteal vessels.
Who cannot join
- Anatomy or size of vessels that did not allow appropriate usage of the devices, following IFU of the devices.
- Known contraindication and/or allergy to (a component of) the device as described in the IFU of the devices.
- Women who were pregnant or lactating at the time of the procedure.
- Life expectancy of less than 12 months at the time of procedure.
- Any patient who was hemodynamically unstable at onset of procedure.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Austria4 sites
Medizinische Universität Innsbruck
Innsbruck, 6020
KABEG-Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Universitätsklinikum St. Pölten - Lilienfeld
Sankt Pölten, 3100
Medizinische Universität WienMedizinische Universität Wien
Vienna, 1090
France4 sites
Public health establishment, Arras Hospital
Arras, 31059
Hospital de la Timone
Marseille, 13354
The Public Hospital, Centre Hospitalier Universitaire de Toulouse
Toulouse, 31059
Clinique River Gauche
Toulouse, 31300
About this study
Official title: A Retrospective PMCF Study Evaluating the Safety and Clinical Performance of the S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter for the Endovascular Interventions in the Ilio-femoropopliteal Vessels
The rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least 1 of the products (named above) from Cordis US Corp.
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Serious Adverse Events
Acute primary Safety Endpoint:
Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) during the procedure and up to 30 days after the procedure.
Measured: 30 days
Freedom from Serious Adverse Events
Primary Safety Endpoint:
Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) up to 12 months after the procedure.
Measured: 12 months
Technical success rate
Acute Primary Efficacy Endpoint:
Technical success rate defined as successful crossing, introduction, deployment (stents)/deflation (balloon catheter) and a <30% residual stenosis on visual assessment of S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter according to the respective IFU.
Measured: During the procedure
Freedom from clinically-driven target lesion revascularization
Primary Efficacy Endpoint:
The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any reintervention at the target lesion due to symptoms.
Measured: 12 months
Secondary outcomes (13)
Technical success rate
Technical success rate defined as successful crossing, introduction, deployment and successful completion of the procedure of the Cordis guidewires (Emerald, ATW, Stablizer, Storq, SV 0.018", Wizdom) and/or the Cordis guiding catheters (Adroit, Vista Brite Tip) and/or the Cordis diagnostic catheters (Super Torque, Super Torque MB, Super Torque Plus, Infiniti 4F/5F/6F, Tempo 4F, Tempo Aqua, High Flow, Pigtail Straightener) and/or the Cordis vascular access devices (Avanti+, Brite Tip, Vista Brite IG, vessel dilator) and/or the Cordis vascular closure devices (MynxGrip and Mynx Control) and/or the Cordis OUTBACK CTO catheters according to the respective IFU.
Measured: During the procedure
Technical success rate
Technical success rate defined as successful hemostasis without conversion to manual/mechanical compression of the Cordis vascular closure devices (MynxGrip and Mynx Control) according to the respective IFU.
Measured: Day of procedure
Freedom from CD-TLR
Freedom from clinically-driven target lesion revascularization (CD-TLR) at 36- and 60-months, defined as any reintervention at the target lesion due to symptoms.
Measured: 36- and 60-months
Stent fracture rate
Stent fracture rate assessed at up to 30 days post-procedure, 12-, 36- and 60-months.
Measured: Up to 30 days post-procedure, 12-, 36- and 60-months
Stent migration rate
Stent migration rate assessed at up to 30 days post-procedure, 12-, 36- and 60-months.
Measured: Up to 30 days post-procedure, 12-, 36- and 60-months
Change of Ankle Brachial Index
Change of Ankle Brachial Index (ABI) assessed at up to 30 days post-procedure, 12-, 36- and 60-months compared to baseline ABI.
Measured: Up to 30 days post-procedure, 12-, 36- and 60-months
Time-to-hemostasis
Time-to-hemostasis assessed for the Cordis vascular closure devices (MynxGrip and Mynx Control). Categorized as Hemostatic time category (HTC) ≤2, HTC >2 to ≤4, HTC >4 to ≤5, HTC >5 to ≤7, HTC >7 to ≤10 min.
Measured: Day of procedure
Time-to-ambulation
Time-to-ambulation assessed for the Cordis vascular closure devices (MynxGrip and Mynx Control) defined as time between end of the procedure and ambulation in hours.
Measured: Day of procedure
Rate of Major Amputation free survival
Rate of Major Amputation free survival defined as any amputation above the knee assessed at up to 30 days post-procedure, 12-, 36- and 60-months.
Measured: Up to 30 days post-procedure, 12-, 36- and 60-months
Clinical success
Clinical success at up to 30 days post procedure, 12-, 36- and 60-months, defined as an improvement of the Rutherford Classification of one class or more, as compared to the pre-procedure Rutherford Classification.
Measured: Up to 30 days post-procedure, 12-, 36- and 60-months
Vessel perforation/dissection
Vessel perforation/dissection during the procedure.
Measured: During the procedure
Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs)
Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs) at 36- and 60-months after the procedure.
Measured: 36- and 60-months
All cause of mortality
All cause of mortality through life of the study.
Measured: procedure through study completion (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Jun 2022
- Primary completion7 Oct 2022
- Study completion7 Nov 2022
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
- Retrospective
- Enrolment
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FCRE (Foundation for Cardiovascular Research and Education)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312580
- Sponsor's protocol ID
- FCRE-220105_ATK
- Status last verified
- Jul 2023
- First submitted
- 28 Mar 2022
- Last updated
- 27 Jul 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective PMCF Study Evaluating the Safety and Clinical Performance of the S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter for the Endovascular Interventions in the Ilio-femoropopliteal Vessels
- ClinicalTrials.gov ID
- NCT05312580
- Acronym / sponsor ID
- FCRE-220105_ATK
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Collaborators
- FCRE (Foundation for Cardiovascular Research and Education)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 7 Oct 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 5 Apr 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 rationale of this study is to confirm and support the clinical safety and performance of the products in a real-word population of 350 patients who underwent an endovascular intervention within standard-of-care (SOC) of the ilio-femoropopliteal artery, using at least 1 of the products (named above) from Cordis US Corp.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with at least one of the above mentioned study devices.
Key inclusion criteria (3 listed)
- Patient is >18 years old at conduction of the procedure.
- Patient who underwent endovascular procedure of the ilio-femoropopliteal vessel with at least one of the following the S.M.A.R.T. Flex Stent Iliac and/or S.M.A.R.T. Flex SFA/PP and/or S.M.A.R.T. Control Nitinol Stent and/or S.M.A.R.T. Nitinol Stent and/or PALMAZ Blue .018 Peripheral Stent on Slalom and/or PALMAZ Genesis .035 Peripheral Stent on Opta Pro and/or SABER OTW PTA Catheter and/or SABERX PTA Dilatation Catheter and/or PowerFlex Pro PTA Catheter as described in the IFU of the devices.
- Target Lesion is located in the ilio-femoropopliteal vessels.
Key exclusion criteria (5 listed)
- Anatomy or size of vessels that did not allow appropriate usage of the devices, following IFU of the devices.
- Known contraindication and/or allergy to (a component of) the device as described in the IFU of the devices.
- Women who were pregnant or lactating at the time of the procedure.
- Life expectancy of less than 12 months at the time of procedure.
- Any patient who was hemodynamically unstable at onset of procedure.
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
Freedom from Serious Adverse Events
Time frame: 30 days
Acute primary Safety Endpoint: Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) during the procedure and up to 30 days after the procedure.
Freedom from Serious Adverse Events
Time frame: 12 months
Primary Safety Endpoint: Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Effect (SADEs) up to 12 months after the procedure.
Technical success rate
Time frame: During the procedure
Acute Primary Efficacy Endpoint: Technical success rate defined as successful crossing, introduction, deployment (stents)/deflation (balloon catheter) and a <30% residual stenosis on visual assessment of S.M.A.R.T. Flex Stent Iliac, S.M.A.R.T. Flex SFA/PP, S.M.A.R.T. Control Nitinol Stent, S.M.A.R.T. Nitinol Stent, PALMAZ Blue .018 Peripheral Stent on Slalom, PALMAZ Genesis .035 Peripheral Stent on Opta Pro, SABER OTW PTA Catheter, SABERX PTA Dilatation Catheter and PowerFlex Pro PTA Catheter according to the respective IFU.
Freedom from clinically-driven target lesion revascularization
Time frame: 12 months
Primary Efficacy Endpoint: The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any reintervention at the target lesion due to symptoms.
13 secondary outcomes
Technical success rate
Time frame: During the procedure
Technical success rate
Time frame: Day of procedure
Freedom from CD-TLR
Time frame: 36- and 60-months
Stent fracture rate
Time frame: Up to 30 days post-procedure, 12-, 36- and 60-months
Stent migration rate
Time frame: Up to 30 days post-procedure, 12-, 36- and 60-months
Change of Ankle Brachial Index
Time frame: Up to 30 days post-procedure, 12-, 36- and 60-months
Time-to-hemostasis
Time frame: Day of procedure
Time-to-ambulation
Time frame: Day of procedure
Rate of Major Amputation free survival
Time frame: Up to 30 days post-procedure, 12-, 36- and 60-months
Clinical success
Time frame: Up to 30 days post-procedure, 12-, 36- and 60-months
Vessel perforation/dissection
Time frame: During the procedure
Freedom from Serious Adverse Events (SAEs) and Serious Adverse Device Events (SADEs)
Time frame: 36- and 60-months
All cause of mortality
Time frame: procedure through study completion (12 months)
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 27 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Peripheral Arterial Disease
Recruiting
Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
Peripheral Arterial Disease, Intermittent Claudication
Active, not recruitingPhase 1
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia
Familial Erythromelalgia
RecruitingPhase 4
Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention
Percutaneous Coronary Intervention, Peripheral Endovascular Intervention
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingPhase 1
A Bioequivalence and Safety Study of AJU-B718 and B718R in Healthy Adult Volunteers Under Fasting Conditions
Peripheral Arterial Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Femoropopliteal Stenosis, run by Cordis US Corp. at 9 sites in 3 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 3 inclusion and 5 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Austria, France, 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?
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?
Freedom from Serious Adverse Events (time frame: 30 days). The study lists 4 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 27 Jul 2023.