NCT03327961

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,111

participants targeted

Target at P75+ for all trials

Timeline
105mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Dec 2017Dec 2034

First Submitted

Initial submission to the registry

October 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

December 2, 2017

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2034

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

12.1 years

First QC Date

October 27, 2017

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Study Arms (1)

scaffold

Patients receiving during PCI the implantation of at least one scaffold

Device: scaffold

Interventions

scaffoldDEVICE

implantation of scaffold (eg Magmaris, Desolve, Others)

scaffold

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.

You may qualify if:

  • subjects \>18 years
  • sign of the patients informed consent
  • implanation of at least one scaffold

You may not qualify if:

  • inability to garantuee at least one year follow-up
  • inabiliuty to garantuee at least one year compliance to dual antiplatelet regimen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

AO San Giovanni di Dio

Agrigento, Agrigento, Italy

RECRUITING

Ospedale Caravaggio-Treviglio

Treviglio, Bergamo, Italy

RECRUITING

Azienda Ospedaliera Universitaria di Bologna

Bologna, Bologna, Italy

RECRUITING

U.O. Cardiologia, Ospedale Maggiore

Bologna, Bologna, Italy

RECRUITING

Ospedale SS Annunziata

Savigliano, Cuneo, Italy

RECRUITING

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

RECRUITING

U.O. Cardiologia, Ospedale Morgagni Pierantoni

Forlì, Forlì-Cesena, Italy

RECRUITING

U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico

Modena, Modena, Italy

RECRUITING

U.O. Cardiologia, Ospedale di Baggiovara

Modena, Modena, Italy

RECRUITING

U.O. di Cardiologia, Azienda Ospedaliero-Universitaria di Parma

Parma, Parma, Italy

RECRUITING

Ospedale Guglielmo da Saliceto

Piacenza, Piacenza, Italy

RECRUITING

Maria Cecilia Hospital - GVM Care & Research

Cotignola, Ravenna, Italy

RECRUITING

U.O. di Cardiologia, Ospedale Santa Maria delle Croci

Ravenna, Ravenna, Italy

RECRUITING

U.O. di Cardiologia, Ospedale degli Infermi

Rimini, Rimini, Italy

RECRUITING

AOU San Luigi Gonzaga

Orbassano, Torino, Italy

RECRUITING

Ospedale di Rivoli

Rivoli, Torino, Italy

RECRUITING

Ospedale di Sanremo

Sanremo, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Veronica Lodolini

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 27, 2017

First Posted

November 1, 2017

Study Start

December 2, 2017

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2034

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations