Coronary Artery DiseaseSHERPA-MAGICNCT03327961
Scaffold in Emilia Romagna and in the MAGIC Network
An observational study of Coronary Artery Disease, run by University Hospital of Ferrara at 17 sites in Italy.
Trial summary
The prospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world regional setting. The protocol includes two different networks. The first network includes all cath-labs in the Emilia-Romagna region (SHERPA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- scaffold
- Type of treatment
- Medical device
- How many people
- 1,111 participants
- Where
- 17 sitesItaly
- Study dates
- 2 Dec 2017to 31 Dec 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.
Who may be able to join
- subjects >18 years
- sign of the patients informed consent
- implanation of at least one scaffold
Who cannot join
- inability to garantuee at least one year follow-up
- inabiliuty to garantuee at least one year compliance to dual antiplatelet regimen
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
Italy17 sites, 17 recruiting
- Recruiting
AO San Giovanni di Dio
Agrigento, Agrigento
Salvatore Geraci
- Recruiting
Azienda Ospedaliera Universitaria di Bologna
Bologna, Bologna
Francesco Saia, MD
- Recruiting
U.O. Cardiologia, Ospedale Maggiore
Bologna, Bologna
Gianni Casella, MD
- Recruiting
University Hospital of Ferrara
Cona, Ferrara, 44124
Simone Biscaglia, MD, +390532239883, bscsmn@unife.it
Gianluca Campo, MD
- Recruiting
Maria Cecilia Hospital - GVM Care & Research
Cotignola, Ravenna
Paolo Sbarzaglia, MD
- Recruiting
U.O. Cardiologia, Ospedale Morgagni Pierantoni
Forlì, Forlì-Cesena
Fabio Tarantino, MD
- Recruiting
U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico
Modena, Modena
Fabio Sgura
- Recruiting
U.O. Cardiologia, Ospedale di Baggiovara
Modena, Modena
Daniele Iaccarino, MD
- Recruiting
AOU San Luigi Gonzaga
Orbassano, Torino
Enrico Cerrato
- Recruiting
U.O. di Cardiologia, Azienda Ospedaliero-Universitaria di Parma
Parma, Parma
Alberto Menozzi, MD
- Recruiting
Ospedale Guglielmo da Saliceto
Piacenza, Piacenza
Luciano Losi, MD
- Recruiting
U.O. di Cardiologia, Ospedale Santa Maria delle Croci
Ravenna, Ravenna
Marco Balduccelli, MD
- Recruiting
U.O. di Cardiologia, Ospedale degli Infermi
Rimini, Rimini
Andrea Santarelli, MD
- Recruiting
Ospedale di Rivoli
Rivoli, Torino
Fernando Varbella
- Recruiting
Ospedale di Sanremo
Sanremo
Massimo Leoncini
- Recruiting
Ospedale SS Annunziata
Savigliano, Cuneo
Baldassarre Doronzo
- Recruiting
Ospedale Caravaggio-Treviglio
Treviglio, Bergamo
Paolo Sganzerla
About this study
Official title: Scaffold Implantation in Emilia-Romagna Plus Multi Absorbable Gears Intra Coronary
The prospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world regional setting. The protocol includes two different networks. The first network includes all cath-labs in the Emilia-Romagna region (SHERPA). The second includes the centers partecipating into the MAGIC retrospective study. Both networks joined into the prospective SHERPA-MAGIC project. Investigators from both networks agreed in indications and strategy implanatation described by the protocol. In each center, after IRB approval, the patients will be enrolled according to established criteria.
Read the detailed description
Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy. Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.
The aim of this observational prospective study is to investigate the clinical performance and long-term safety of scaffold in a real world regional setting.
The investigators agreed in the following preferential/optimal indications:
- complete revascularization in patients with age <65 years
- revascularization of long lesions (>24 mm), especially located in left anterior descending
- spontaneous coronary dissection
The investigators agreed in the following strategy implantation:
- mandatory predilatation
- sizing 1:1
- to avoid vessel with reference vessel diameter <2.8 mm and >3.8 mm
- to avoid vessel with severe calcifications
- mandatory postdilation with non compliant balloon ≥0.5 the scaffold diameter
The study organization is based on:
DATA SAFETY MONITORING BOARD (DSMB) All adverse events will be reported to the DSMB and reviewed on an on-going basis throughout the subject enrolment and follow-up period to ensure the safety of subjects enrolled in this study. The DSMB may request additional information as needed.
CORE LABORATORY ANALYSIS All coronary artery angiographies and percutaneous coronary interventions will be reviewed by an indipendent core-lab. The core-lab will perform quantitative coronary analysis and assessment of the agreement between implantation technique in each case and established criteria
- Conditions
- Coronary Artery Disease
- Being tested
- scaffold
- 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.
scaffoldDevice
implantation of scaffold (eg Magmaris, Desolve, Others)
| Study group | Role | What they receive |
|---|---|---|
| scaffold | Patients receiving during PCI the implantation of at least one scaffold Receives: Device: scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Oriented Cardiac Events
cumulative occurence of cardiovascular death, target vessel myocardial infarction and target vessel revascularization. Target is defined the vessel treated with scaffold
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 Nov 2017
- Study start2 Dec 2017
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Prospective
- Enrolment
- 1,111 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327961
- Sponsor's protocol ID
- 170899
- Acronym
- SHERPA-MAGIC
- Status last verified
- Apr 2026
- First submitted
- 27 Oct 2017
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaffold Implantation in Emilia-Romagna Plus Multi Absorbable Gears Intra Coronary
- ClinicalTrials.gov ID
- NCT03327961
- Acronym / sponsor ID
- SHERPA-MAGIC / 170899
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,111 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 2 Dec 2017 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 1 Nov 2017 (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 prospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world regional setting. The protocol includes two different networks. The first network includes all cath-labs in the Emilia-Romagna region (SHERPA). The second includes the centers partecipating into the MAGIC retrospective study. Both networks joined into the prospective SHERPA-MAGIC project. Investigators from both networks agreed in indications and strategy implanatation described by the protocol. In each center, after IRB approval, the patients will be enrolled according to established criteria.
Detailed description
Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy. Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.
The aim of this observational prospective study is to investigate the clinical performance and long-term safety of scaffold in a real world regional setting.
The investigators agreed in the following preferential/optimal indications:
- complete revascularization in patients with age <65 years
- revascularization of long lesions (>24 mm), especially located in left anterior descending
- spontaneous coronary dissection
The investigators agreed in the following strategy implantation:
- mandatory predilatation
- sizing 1:1
- to avoid vessel with reference vessel diameter <2.8 mm and >3.8 mm
- to avoid vessel with severe calcifications
- mandatory postdilation with non compliant balloon ≥0.5 the scaffold diameter
The study organization is based on:
DATA SAFETY MONITORING BOARD (DSMB) All adverse events will be reported to the DSMB and reviewed on an on-going basis throughout the subject enrolment and follow-up period to ensure the safety of subjects enrolled in this study. The DSMB may request additional information as needed.
CORE LABORATORY ANALYSIS All coronary artery angiographies and percutaneous coronary interventions will be reviewed by an indipendent core-lab. The core-lab will perform quantitative coronary analysis and assessment of the agreement between implantation technique in each case and established criteria
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| scaffold | – | Device: scaffoldPatients receiving during PCI the implantation of at least one scaffold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.
Key inclusion criteria (3 listed)
- subjects >18 years
- sign of the patients informed consent
- implanation of at least one scaffold
Key exclusion criteria (2 listed)
- inability to garantuee at least one year follow-up
- inabiliuty to garantuee at least one year compliance to dual antiplatelet regimen
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 |
|---|---|---|
| scaffoldimplantation of scaffold (eg Magmaris, Desolve, Others) | Device | scaffold |
Primary outcome
Device Oriented Cardiac Events
Time frame: 1 year
cumulative occurence of cardiovascular death, target vessel myocardial infarction and target vessel revascularization. Target is defined the vessel treated with scaffold
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: 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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University Hospital of Ferrara at 17 sites 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronica Lodolini (0532236450 ext. +39, ldlvnc@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Oriented Cardiac Events (time frame: 1 year). 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 1 May 2026.