Aortic Valve StenosisASCOPNCT05750927
Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes
An observational study of Aortic Valve Stenosis and Transcatheter Aortic Valve Replacement, run by Niguarda Hospital at 1 site in Italy.
Trial summary
To describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Angioplasty, Balloon, Coronary
- What is being tested?
- Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2022to 31 Dec 2023
- 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
- Adult, Older adult
Study population: Severe, symptomatic aortic stenosis with an indication to TAVI 2. Concomitant, stable CAD with an indication to complex PCI, as anticipated by angiography, defined as follows (one or more features)
- Severe, symptomatic aortic stenosis with an indication to TAVI
- Concomitant, stable CAD with an indication to complex PCI, as anticipated by angiography, defined as follows (one or more features)
- Left-main (LM) CAD or proximal left anterior descending (LAD) / left circumflex (LCx) lesions requiring LM-PCI
- Three-vessel disease
- Last remaining vessel
- Bifurcation PCI (proximal bifurcation)
- Severely calcified lesions requiring calcium plaque modification (rotational/orbital atherectomy, intravascular lithotripsy, scoring or cutting balloon)
- Lesion length > 30 mm
- Severely depressed Left ventricular function requiring mechanical circulatory support (intra-aortic balloon pump - IABP, Impella, Extracorporeal Membrane Oxygenation - ECMO
Trial locations and contacts
1 site in 1 country.
About this study
To describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI
Read the detailed description
The aims of this study are:
- to describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI
- to depict the different possible strategies that are currently employed in this context and to retrospectively analyze outcomes
- to investigate predictors of better outcomes
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Angioplasty, Balloon, Coronary, Coronary Artery Disease
- Being tested
- Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)
- Medical subject headings
- Aortic Valve Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)Procedure or surgery
TAVI and PCI to be administered as per physician's indication and choice, in one or more stages
| Study group | Role | What they receive |
|---|---|---|
| ASCoP (severe Aortic Stenosis with Complex PCI features) | Subjects with severe aortic stenosis undergoing transcatheter aortic valve intervention and with concomitant, complex coronary artery disease with a clinical indication for percutaneous coronary intervention Receives: Procedure: Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
POCE
all-cause deaths, strokes (any), myocardial infarction and major bleedings
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Dec 2022
- Primary completion1 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750927
- Sponsor's protocol ID
- 723-1412202
- Acronym
- ASCOP
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Publications
Montalto C, Munafo AR, Soriano F, Arslani K, Brunner S, Verhemel S, Cozzi O, Mangieri A, Buono A, Squillace M, Nava S, Diez Gil JL, Scotti A, Foroni M, Esposito G, Mandurino-Mirizzi A, Bauer D, Ornelas B, Codner P, Piayda K, Porto I, Marco F, Sievert H, Kornowski R, Tousek P, Fischetti D, Latib A, Sanchez JS, Maffeo D, Bedogni F, Reimers B, Regazzoli D, Mieghem NV, Sondergaard L, Saia F, Toggweiler S, Backer O, Oreglia JA. Outcomes of complex, high-risk percutaneous coronary intervention in patients with severe aortic stenosis: the ASCoP registry. EuroIntervention. 2025 Apr 21;21(8):e426-e436. doi: 10.4244/EIJ-D-24-00933.
PubMed 40259842
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Stenosis With COmplex PCI (ASCOP) Features Retrospective Registry on Contemporary Management and Outcomes
- ClinicalTrials.gov ID
- NCT05750927
- Acronym / sponsor ID
- ASCOP / 723-1412202
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Angioplasty, Balloon, Coronary, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Mar 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.
To describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI
Detailed description
The aims of this study are:
- to describe the prevalence and clinical features of patients with severe aortic stenosis undergoing TAVI and concomitant clinically indicated, complex and/or high-risk PCI
- to depict the different possible strategies that are currently employed in this context and to retrospectively analyze outcomes
- to investigate predictors of better outcomes
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASCoP (severe Aortic Stenosis with Complex PCI features) | – | Procedure: Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)Subjects with severe aortic stenosis undergoing transcatheter aortic valve intervention and with concomitant, complex coronary artery disease with a clinical indication for percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Severe, symptomatic aortic stenosis with an indication to TAVI 2. Concomitant, stable CAD with an indication to complex PCI, as anticipated by angiography, defined as follows (one or more features)
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 |
|---|---|---|
| Transcatheter aortic valve intervention (TAVI) and percutaneous coronary intervention (PCI)TAVI and PCI to be administered as per physician's indication and choice, in one or more stages | Procedure or surgery | ASCoP (severe Aortic Stenosis with Complex PCI features) |
Primary outcome
POCE
Time frame: 1 year
all-cause deaths, strokes (any), myocardial infarction and major bleedings
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 21 Mar 2024.
- Derived from this study: PubMed 40259842Montalto C, Munafo AR, Soriano F, Arslani K, Brunner S, Verhemel S, Cozzi O, Mangieri A, Buono A, Squillace M, Nava S, Diez Gil JL, Scotti A, Foroni M, Esposito G, Mandurino-Mirizzi A, Bauer D, Ornelas B, Codner P, Piayda K, Porto I, Marco F, Sievert H, Kornowski R, Tousek P, Fischetti D, Latib A, Sanchez JS, Maffeo D, Bedogni F, Reimers B, Regazzoli D, Mieghem NV, Sondergaard L, Saia F, Toggweiler S, Backer O, Oreglia JA. Outcomes of complex, high-risk percutaneous coronary intervention in patients with severe aortic stenosis: the ASCoP registry. EuroIntervention. 2025 Apr 21;21(8):e426-e436. doi: 10.4244/EIJ-D-24-00933.
- Individual participant dataSharing planned: Undecided. undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aortic Valve Stenosis and Transcatheter Aortic Valve Replacement, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Mar 2024. 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 Italy. 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?
POCE (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05750927, which also lists 1 linked publication.
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 21 Mar 2024.