Percutaneous Coronary Intervention (PCI)COILSEALNCT06720935
Use of Coils During Percutaneous Coronary Intervention
An observational study of Percutaneous Coronary Intervention (PCI) and Coronary Artery Disease, run by San Luigi Gonzaga Hospital at 1 site in Italy.
Trial summary
Use of coils during percutaneous coronary interventions (PCI) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes. The study aims to report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Percutaneous Coronary Intervention (PCI), Coronary Artery Disease
- How many people
- 143 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 28 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with coronary artery perforation or coronary fistula/aneurysm treated with coils embolization during percutaneous coronary intervention
Who may be able to join
- Patients with coronary artery perforation or coronary artery fistula/aneurysm suitable treating with coils embolization
Who cannot join
- Patients without coronary artery disease suitable of coils treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contemporary Use of Coils During Percutaneous Coronary Intervention: From the Multicenter COILSEAL Registry
Use of coils during percutaneous coronary interventions (PCI) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes. The study aims to report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or closing coronary aneurysms/fistulas.
Read the detailed description
Background. Use of coils during percutaneous coronary interventions (PCI) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes Objectives. To report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or closing coronary aneurysms/fistulas.
Methods. Among 245.652 PCIs performed in 17 high-volume European centers, patients treated with coils will be identified.
The primary outcome was technical success, defined as the successful sealing coronary perforation or aneurysm/fistulas and procedural success defined as technical success without in-hospital Major Cardiovascular Events (MACe). Long-term MACE and mortality were also reported
- Keywords
- Coils, Coronary Artery Perforation, Coronary Fistulas, Coronary aneurysm
- Medical subject headings
- Coronary Artery Disease, Coronary Aneurysm
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 |
|---|---|---|
| Patients undergoing to percutaneous coronary intervention with coils | The study involves patients undergoing coils embolization for treating coronary artery perforation or coronary fistulas/aneurysm during percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Technical Success
Rate of technical success is defined as effective sealing of coronary perforation or coronary fistulas/aneurysm after coils embolization
Measured: intraprocedural
Secondary outcomes (1)
Rate of Procedural success
Rate of technical success without In Hospital Major Cardiovascular Events including death, target vessel myocardial infarction and re-PCI or CABG
Measured: Intraprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start1 Jan 2024
- Primary completion1 Sep 2024
- Study completion28 Sep 2024
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 Percutaneous Coronary Intervention (PCI)Studies 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
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Luigi Gonzaga Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Cerrato, San Luigi Gonzaga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720935
- Sponsor's protocol ID
- 002-2024
- Acronym
- COILSEAL
- Status last verified
- Dec 2024
- First submitted
- 29 Sep 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cerrato E, Piedimonte G, Franzino M, Marengo G, Bollati M, Zecchino S, Rutigliano D, Soriano F, Leoncini M, Mangione R, Sagazio E, Maiellaro F, Jeva F, Ussia GP, Scudiero F, Franze A, Barbero U, Calderone D, Nicolino A, Ugo F, La Manna A, Costa F, Mazzarotto P, Amat-Santos IJ, Varbella F; CardioGroupVIII-COILSEAL Study Group. Contemporary Use of Coils During Percutaneous Coronary Intervention: Insights From the Multicenter COILSEAL Registry. Catheter Cardiovasc Interv. 2025 Dec;106(7):3888-3898. doi: 10.1002/ccd.70233. Epub 2025 Oct 21.
PubMed 41121637
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contemporary Use of Coils During Percutaneous Coronary Intervention: From the Multicenter COILSEAL Registry
- ClinicalTrials.gov ID
- NCT06720935
- Acronym / sponsor ID
- COILSEAL / 002-2024
- Keywords
- Coils, Coronary Artery Perforation, Coronary Fistulas, Coronary aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- San Luigi Gonzaga HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 28 Sep 2024 (actual)
- First posted
- 6 Dec 2024 (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.
Use of coils during percutaneous coronary interventions (PCI) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes. The study aims to report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or closing coronary aneurysms/fistulas.
Detailed description
Background. Use of coils during percutaneous coronary interventions (PCI) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes Objectives. To report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or closing coronary aneurysms/fistulas.
Methods. Among 245.652 PCIs performed in 17 high-volume European centers, patients treated with coils will be identified.
The primary outcome was technical success, defined as the successful sealing coronary perforation or aneurysm/fistulas and procedural success defined as technical success without in-hospital Major Cardiovascular Events (MACe). Long-term MACE and mortality were also reported
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing to percutaneous coronary intervention with coils | – | –The study involves patients undergoing coils embolization for treating coronary artery perforation or coronary fistulas/aneurysm during percutaneous coronary intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with coronary artery perforation or coronary fistula/aneurysm treated with coils embolization during percutaneous coronary intervention
Key inclusion criteria (1 listed)
- Patients with coronary artery perforation or coronary artery fistula/aneurysm suitable treating with coils embolization
Key exclusion criteria (1 listed)
- Patients without coronary artery disease suitable of coils treatment
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
Rate of Technical Success
Time frame: intraprocedural
Rate of technical success is defined as effective sealing of coronary perforation or coronary fistulas/aneurysm after coils embolization
1 secondary outcome
Rate of Procedural success
Time frame: Intraprocedural
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 6 Dec 2024.
- Derived from this study: PubMed 41121637Cerrato E, Piedimonte G, Franzino M, Marengo G, Bollati M, Zecchino S, Rutigliano D, Soriano F, Leoncini M, Mangione R, Sagazio E, Maiellaro F, Jeva F, Ussia GP, Scudiero F, Franze A, Barbero U, Calderone D, Nicolino A, Ugo F, La Manna A, Costa F, Mazzarotto P, Amat-Santos IJ, Varbella F; CardioGroupVIII-COILSEAL Study Group. Contemporary Use of Coils During Percutaneous Coronary Intervention: Insights From the Multicenter COILSEAL Registry. Catheter Cardiovasc Interv. 2025 Dec;106(7):3888-3898. doi: 10.1002/ccd.70233. Epub 2025 Oct 21.
- Individual participant dataSharing planned: Undecided
Related trials for Percutaneous Coronary Intervention (PCI)
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
RecruitingPhase 3
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
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 Percutaneous Coronary Intervention (PCI) and Coronary Artery Disease, run by San Luigi Gonzaga 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?
The sponsor lists 1 inclusion and 1 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 6 Dec 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?
Rate of Technical Success (time frame: intraprocedural). 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 NCT06720935, 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 6 Dec 2024.