Chronic Total OcclusionSXS-CTONCT03563989
STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion
A study testing Implantation of Stent (PCI) in people with Chronic Total Occlusion and Coronary Artery Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Intro: Chronic total occlusions (CTO) are the most severe coronary lesions. Negative distal vessel remodeling occurs in these lesions, leading to reduction of artery diameter. Treatment of CTO with percutaneous coronary intervention (PCI) is associated with good clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion, Coronary Artery Disease
- What is being tested?
- Implantation of Stent (PCI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2018to Dec 2019
- 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
- age ≥ 18 years;
- CTO referred for PCI
- Diameter of the Target vessel for PCI between 2.5 and 4.5mm
- Agreement to participate and signed informed consent after information
- Affiliation to Social Security System
- French comprehension
- Person under guardianship or curatorship
Who cannot join
- Pregnant women, breast-feeding,
- History of an allergic reaction or significant sensitivity to any stent component or to contrast dye
- Intrastent CTO
- Major calcifications in the CTO
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, 94010
MADJID BOUKANTAR, MD, +33149812111, madjid.boukantar@aphp.fr
About this study
Official title: STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion (SXS-CTO)
Intro: Chronic total occlusions (CTO) are the most severe coronary lesions. Negative distal vessel remodeling occurs in these lesions, leading to reduction of artery diameter. Treatment of CTO with percutaneous coronary intervention (PCI) is associated with good clinical outcomes. However, QCA and IVUS studies showed a notable lumen and vessel enlargement distal to recanalized CTO. In addition, optical tomography (OCT) studies showed high rates of stent strut malapposition and incomplete stent strut coverage after CTO PCI. The Stentys Xposition S is a self-apposing stent device which lowers stent strut malapposition rates. Its safety and effectiveness has been demonstrated in STEMI and stable coronary patients but never investigated in CTO lesions.
Hypothesis/Objective To investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 6 months after implantation in patients with CTO undergoing percutaneous coronary intervention.
Method Pilot randomized study. Patients are randomized to receive either self-expandable stent or balloon expandable stent to perform CTO-PCI. Follow-up coronary angiography is performed at 6 months post-PCI. Stent malapposition is evaluated by OCT.
- Conditions
- Chronic Total Occlusion, Coronary Artery Disease
- Being tested
- Implantation of Stent (PCI)
- Keywords
- Chronic total occlusion, Self-expandable stent, Percutaneous coronary intervention, Coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of Stent (PCI)Device
Treatment of CTO with Percutaneous Coronary Intervention (PCI) Patients are randomized to receive either self-expandable stent or balloon expandable stent
| Study group | Role | What they receive |
|---|---|---|
| Stentys Xposition S Self-Apposing stent | Experimental | STENTYS Xposition S Sirolimus Eluting Self-Apposing Coronary Stent System Receives: Device: Implantation of Stent (PCI) |
| Conventional Balloon-expandable stent | Active comparator | Conventional Balloon-expandable drug eluting stents in effect at the time of the study, in compliance with applicable contracts made between Hospital and suppliers. Receives: Device: Implantation of Stent (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
strut malapposition at six months measured by OCT
Measured: 6 months after CTO-PCI
Secondary outcomes (8)
percentage of uncovered struts
Measured: 6 months after CTO-PCI
lumen diameter (mm)
Measured: 6 months after CTO-PCI
Restenosis
Measured: 6 months after CTO-PCI
Angina pectoris
Measured: 6 months after CTO-PCI
Dyspnea
Measured: 6 months after CTO-PCI
Mortality
Measured: 6 months after CTO-PCI
Stroke
Measured: 6 months after CTO-PCI
Stent thrombosis
Measured: 6 months after CTO-PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start26 Jun 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total OcclusionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563989
- Sponsor's protocol ID
- K171009J
- Acronym
- SXS-CTO
- Status last verified
- May 2018
- First submitted
- 28 May 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STENTYS Xposition S in the Treatment of Chronic Total Artery Occlusion (SXS-CTO)
- ClinicalTrials.gov ID
- NCT03563989
- Acronym / sponsor ID
- SXS-CTO / K171009J
- Conditions
- Chronic Total Occlusion, Coronary Artery Disease
- Keywords
- Chronic total occlusion, Self-expandable stent, Percutaneous coronary intervention, Coronary artery disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 20 Jun 2018 (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.
Intro: Chronic total occlusions (CTO) are the most severe coronary lesions. Negative distal vessel remodeling occurs in these lesions, leading to reduction of artery diameter. Treatment of CTO with percutaneous coronary intervention (PCI) is associated with good clinical outcomes. However, QCA and IVUS studies showed a notable lumen and vessel enlargement distal to recanalized CTO. In addition, optical tomography (OCT) studies showed high rates of stent strut malapposition and incomplete stent strut coverage after CTO PCI. The Stentys Xposition S is a self-apposing stent device which lowers stent strut malapposition rates. Its safety and effectiveness has been demonstrated in STEMI and stable coronary patients but never investigated in CTO lesions.
Hypothesis/Objective To investigate whether self-expanding stents are more effective than balloon-expandable stents for reducing stent malapposition at 6 months after implantation in patients with CTO undergoing percutaneous coronary intervention.
Method Pilot randomized study. Patients are randomized to receive either self-expandable stent or balloon expandable stent to perform CTO-PCI. Follow-up coronary angiography is performed at 6 months post-PCI. Stent malapposition is evaluated by OCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stentys Xposition S Self-Apposing stent | Experimental | Device: Implantation of Stent (PCI)STENTYS Xposition S Sirolimus Eluting Self-Apposing Coronary Stent System |
| Conventional Balloon-expandable stent | Active comparator | Device: Implantation of Stent (PCI)Conventional Balloon-expandable drug eluting stents in effect at the time of the study, in compliance with applicable contracts made between Hospital and suppliers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age ≥ 18 years;
- CTO referred for PCI
- Diameter of the Target vessel for PCI between 2.5 and 4.5mm
- Agreement to participate and signed informed consent after information
- Affiliation to Social Security System
Key exclusion criteria (4 listed)
- Pregnant women, breast-feeding,
- History of an allergic reaction or significant sensitivity to any stent component or to contrast dye
- Intrastent CTO
- Major calcifications in the CTO
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 |
|---|---|---|
| Implantation of Stent (PCI)Treatment of CTO with Percutaneous Coronary Intervention (PCI) Patients are randomized to receive either self-expandable stent or balloon expandable stent | Device | Conventional Balloon-expandable stent, Stentys Xposition S Self-Apposing stent |
Primary outcome
strut malapposition at six months measured by OCT
Time frame: 6 months after CTO-PCI
8 secondary outcomes
percentage of uncovered struts
Time frame: 6 months after CTO-PCI
lumen diameter (mm)
Time frame: 6 months after CTO-PCI
Restenosis
Time frame: 6 months after CTO-PCI
Angina pectoris
Time frame: 6 months after CTO-PCI
Dyspnea
Time frame: 6 months after CTO-PCI
Mortality
Time frame: 6 months after CTO-PCI
Stroke
Time frame: 6 months after CTO-PCI
Stent thrombosis
Time frame: 6 months after CTO-PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
Assistance Publique Hôpitaux de Paris - CHU HENRI MONDOR
Créteil, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of Stent (PCI) in people with Chronic Total Occlusion and Coronary Artery Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 13 Aug 2018. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
strut malapposition at six months measured by OCT (time frame: 6 months after CTO-PCI). 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 13 Aug 2018.