Stent RestenosisRAINNCT03544294
veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study
An observational study of Stent Restenosis and Stent Thrombosis, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial summary
For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stent Restenosis, Stent Thrombosis, Left Main Coronary Artery Disease
- What is being tested?
- Xience alpine, ultimaster, resolute onyx, synergy
- Type of treatment
- Medical device
- How many people
- 2,800 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 30 May 2018
- How long will I take part?
- 6 Months
- 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: consecutive patients undergoing PCI
Who may be able to join
- Patients undergoing PCI on unprotected left main or coronary bifurcation
Who cannot join
- PCI performed on other coronary vessels
Trial locations and contacts
1 site in 1 country.
About this study
For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with very thin stents for ULM or bifurcation.
Read the detailed description
For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Previous studies do not have enough power to detect potential significant difference for ULM or bifurcation lesions. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with Biomatrix Flex, Xience Alpine, Ultimaster, Resolute Onyx and Synergy. MACE (a composite end point of death, myocardial infarction, target lesion revascularization and stent thrombosis) will be the primary end point, while its single components will be the secondary ones.
- Conditions
- Stent Restenosis, Stent Thrombosis, Left Main Coronary Artery Disease, Coronary Bifurcations, Very Thin Stents
- Being tested
- Xience alpine, ultimaster, resolute onyx, synergy
- 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.
Xience alpine, ultimaster, resolute onyx, synergyDevice
PCI will be performed
| Study group | Role | What they receive |
|---|---|---|
| Group | Consecutive patients treated with very thin stents on ULM and bifurcation Receives: Device: Xience alpine, ultimaster, resolute onyx, synergy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events (MACE) is a composite end-point which includes: death for any cause; non fatal myocardial infarction; target lesion revascularization (TLR); in-stent thrombosis.
Measured: 1 year
Secondary outcomes (4)
Target Lesion revascularization (TLR)
The investigators defined Target Lesion Revascularization as either repeat percutaneous or surgical revascularization for a lesion anywhere within the stent or the 5-mm borders proximal or distal to the stent.
Measured: 1 year
Death
Death for any cause (both cardiologic and non-cardiologic)
Measured: 1 year
non fatal myocardial infarction
non fatal myocardial infarction
Measured: 1 year
Target Vessel Revascularization (TVR)
TVR is defined as any repeat PCI in the target vessel indicating the disease progression.
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 posted1 Jun 2018
- Study start1 Jun 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stent RestenosisStudies 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
- 2,800 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Principal investigator, Fabrizio D'Ascenzo, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03544294
- Sponsor's protocol ID
- RAIN
- Acronym
- RAIN
- Status last verified
- Jun 2018
- First submitted
- 18 May 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Choi KH, Nam CW, Bruno F, Cho YK, De Luca L, Kang J, Mattesini A, Song YB, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, Helft G, Han SH, Cortese B, Lee CH, Escaned J, Yoon HJ, Chieffo A, Hahn JY, Gallone G, Choi SH, De Ferrari G, Koo BK, Quadri G, Hur SH, D'Ascenzo F, Gwon HC, de Filippo O. Differential Prognosis of True Bifurcation Lesions According to Left Main Versus Non-Left Main Location and Treatment Strategy. J Am Heart Assoc. 2025 Feb 4;14(3):e037657. doi: 10.1161/JAHA.124.037657. Epub 2025 Feb 3.
PubMed 39895551Choi KH, Bruno F, Cho YK, De Luca L, Song YB, Kang J, Mattesini A, Gwon HC, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, Hur SH, Helft G, Han SH, Cortese B, Lee CH, Escaned J, Yoon HJ, Chieffo A, Hahn JY, Gallone G, Choi SH, De Ferrari G, Koo BK, Quadri G, D'Ascenzo F, Nam CW, de Filippo O. Comparison of Outcomes Between 1- and 2-Stent Techniques for Medina Classification 0.0.1 Coronary Bifurcation Lesions. JACC Cardiovasc Interv. 2023 Sep 11;16(17):2083-2093. doi: 10.1016/j.jcin.2023.06.013. Epub 2023 Aug 9.
PubMed 37565964Iannaccone M, Barbero U, De Benedictis M, Imori Y, Quadri G, Trabattoni D, Ryan N, Venuti G, Montabone A, Wojakowski W, Rognoni A, Helft G, Parma R, De Luca L, Autelli M, Boccuzzi G, Mattesini A, Templin C, Cerrato E, Wanha W, Smolka G, Huczek Z, Tomassini F, Cortese B, Capodanno D, Chieffo A, Nunez-Gil I, Gili S, Bassignana A, di Mario C, Doronzo B, Omede P, D'Amico M, Tedeschi D, Varbella F, Luscher T, Sheiban I, Escaned J, Rinaldi M, D'Ascenzo F. Comparison of bioresorbable vs durable polymer drug-eluting stents in unprotected left main (from the RAIN-CARDIOGROUP VII Study). BMC Cardiovasc Disord. 2020 May 15;20(1):225. doi: 10.1186/s12872-020-01420-5.
PubMed 32414330Gaido L, D'Ascenzo F, Imori Y, Wojakowski W, Saglietto A, Figini F, Mattesini A, Trabattoni D, Rognoni A, Tomassini F, Bernardi A, Ryan N, Muscoli S, Helft G, De Filippo O, Parma R, De Luca L, Ugo F, Cerrato E, Montefusco A, Pennacchi M, Wanha W, Smolka G, de Lio G, Bruno F, Huczek Z, Boccuzzi G, Cortese B, Capodanno D, Omede P, Mancone M, Nunez-Gil I, Romeo F, Varbella F, Rinaldi M, Escaned J, Conrotto F, Burzotta F, Chieffo A, Perl L, D'Amico M, di Mario C, Sheiban I, Gagnor A, Giammaria M, De Ferrari GM. Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations: An Analysis From the RAIN-CARDIOGROUP VII Study. Circ Cardiovasc Interv. 2020 Mar;13(3):e008325. doi: 10.1161/CIRCINTERVENTIONS.119.008325. Epub 2020 Feb 27.
PubMed 32102566
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study
- ClinicalTrials.gov ID
- NCT03544294
- Acronym / sponsor ID
- RAIN / RAIN
- Conditions
- Stent Restenosis, Stent Thrombosis, Left Main Coronary Artery Disease, Coronary Bifurcations, Very Thin Stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 1 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.
For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with very thin stents for ULM or bifurcation.
Detailed description
For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Previous studies do not have enough power to detect potential significant difference for ULM or bifurcation lesions. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with Biomatrix Flex, Xience Alpine, Ultimaster, Resolute Onyx and Synergy. MACE (a composite end point of death, myocardial infarction, target lesion revascularization and stent thrombosis) will be the primary end point, while its single components will be the secondary ones.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Device: Xience alpine, ultimaster, resolute onyx, synergyConsecutive patients treated with very thin stents on ULM and bifurcation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients undergoing PCI
Key inclusion criteria (1 listed)
- Patients undergoing PCI on unprotected left main or coronary bifurcation
Key exclusion criteria (1 listed)
- PCI performed on other coronary vessels
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 |
|---|---|---|
| Xience alpine, ultimaster, resolute onyx, synergyPCI will be performed | Device | Group |
Primary outcome
Major Adverse Cardiac Events (MACE)
Time frame: 1 year
Major Adverse Cardiac Events (MACE) is a composite end-point which includes: death for any cause; non fatal myocardial infarction; target lesion revascularization (TLR); in-stent thrombosis.
4 secondary outcomes
Target Lesion revascularization (TLR)
Time frame: 1 year
Death
Time frame: 1 year
non fatal myocardial infarction
Time frame: 1 year
Target Vessel Revascularization (TVR)
Time frame: 1 year
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 Jun 2018.
- Derived from this study: PubMed 39895551Choi KH, Nam CW, Bruno F, Cho YK, De Luca L, Kang J, Mattesini A, Song YB, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, Helft G, Han SH, Cortese B, Lee CH, Escaned J, Yoon HJ, Chieffo A, Hahn JY, Gallone G, Choi SH, De Ferrari G, Koo BK, Quadri G, Hur SH, D'Ascenzo F, Gwon HC, de Filippo O. Differential Prognosis of True Bifurcation Lesions According to Left Main Versus Non-Left Main Location and Treatment Strategy. J Am Heart Assoc. 2025 Feb 4;14(3):e037657. doi: 10.1161/JAHA.124.037657. Epub 2025 Feb 3.
- Derived from this study: PubMed 37565964Choi KH, Bruno F, Cho YK, De Luca L, Song YB, Kang J, Mattesini A, Gwon HC, Truffa A, Kim HS, Wanha W, Chun WJ, Gili S, Hur SH, Helft G, Han SH, Cortese B, Lee CH, Escaned J, Yoon HJ, Chieffo A, Hahn JY, Gallone G, Choi SH, De Ferrari G, Koo BK, Quadri G, D'Ascenzo F, Nam CW, de Filippo O. Comparison of Outcomes Between 1- and 2-Stent Techniques for Medina Classification 0.0.1 Coronary Bifurcation Lesions. JACC Cardiovasc Interv. 2023 Sep 11;16(17):2083-2093. doi: 10.1016/j.jcin.2023.06.013. Epub 2023 Aug 9.
- Derived from this study: PubMed 32414330Iannaccone M, Barbero U, De Benedictis M, Imori Y, Quadri G, Trabattoni D, Ryan N, Venuti G, Montabone A, Wojakowski W, Rognoni A, Helft G, Parma R, De Luca L, Autelli M, Boccuzzi G, Mattesini A, Templin C, Cerrato E, Wanha W, Smolka G, Huczek Z, Tomassini F, Cortese B, Capodanno D, Chieffo A, Nunez-Gil I, Gili S, Bassignana A, di Mario C, Doronzo B, Omede P, D'Amico M, Tedeschi D, Varbella F, Luscher T, Sheiban I, Escaned J, Rinaldi M, D'Ascenzo F. Comparison of bioresorbable vs durable polymer drug-eluting stents in unprotected left main (from the RAIN-CARDIOGROUP VII Study). BMC Cardiovasc Disord. 2020 May 15;20(1):225. doi: 10.1186/s12872-020-01420-5.
- Derived from this study: PubMed 32102566Gaido L, D'Ascenzo F, Imori Y, Wojakowski W, Saglietto A, Figini F, Mattesini A, Trabattoni D, Rognoni A, Tomassini F, Bernardi A, Ryan N, Muscoli S, Helft G, De Filippo O, Parma R, De Luca L, Ugo F, Cerrato E, Montefusco A, Pennacchi M, Wanha W, Smolka G, de Lio G, Bruno F, Huczek Z, Boccuzzi G, Cortese B, Capodanno D, Omede P, Mancone M, Nunez-Gil I, Romeo F, Varbella F, Rinaldi M, Escaned J, Conrotto F, Burzotta F, Chieffo A, Perl L, D'Amico M, di Mario C, Sheiban I, Gagnor A, Giammaria M, De Ferrari GM. Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations: An Analysis From the RAIN-CARDIOGROUP VII Study. Circ Cardiovasc Interv. 2020 Mar;13(3):e008325. doi: 10.1161/CIRCINTERVENTIONS.119.008325. Epub 2020 Feb 27.
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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 Stent Restenosis and Stent Thrombosis, run by A.O.U. Città della Salute e della Scienza 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 Jun 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 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?
Major Adverse Cardiac Events (MACE) (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 NCT03544294, which also lists 4 linked publications.
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 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.