NCT04098042

Brief Summary

The retrospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world setting including high volume PCI centers in Italy

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

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 Start

First participant enrolled

July 30, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

3 years

First QC Date

September 9, 2019

Last Update Submit

February 22, 2020

Conditions

Coronary Artery DiseaseMyocardial Infarction

Keywords

Bioresorbable scaffoldsMagnesium made bioresorbable scaffoldsMagmariscoronary artery diseasePercutaneous coronary interventionMyocardia infarctionmultivessel coronary disease

Outcome Measures

Primary Outcomes (1)

  • Device Oriented Cardiac Events (DOCE) rate

    Rate of DOCE, a composite of cardiovascular death, target vessel myocardial infarction and target lesion revascularization.

    1 year

Secondary Outcomes (3)

  • Cardiac death rate

    1 year

  • Target vessel myocardial infarction rate

    1 year

  • Target lesion revascularization rate

    1 year

Study Arms (1)

Scaffold

Patients receiving during PCI the implantation of at least one Magnesium Made Bioresorbable Scaffold "Magmaris"

Device: Scaffold

Interventions

ScaffoldDEVICE

implantation of a Magmaris scaffold

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
  • Able to provide an informed consent
  • implantation of at least one scaffold

You may not qualify if:

  • inability to provide at least one year follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

Interventional Unit, San Luigi Gonzaga University Hospital, Orbassano, and Rivoli Hospital, Turin, Italy

Turin, 10100, Italy

Location

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 20, 2019

Study Start

July 30, 2016

Primary Completion

July 30, 2019

Study Completion

July 30, 2023

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

IT(2)