Scaffold in Emilia Romagna and in the MAGIC Network
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital of Ferrara
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
subjects >18 years
sign of the patients informed consent
implanation of at least one scaffold
Disqualifiers
inability to garantuee at least one year follow-up
inabiliuty to garantuee at least one year compliance to dual antiplatelet regimen
Trial population
Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
scaffold
Deviceimplantation of scaffold (eg Magmaris, Desolve, Others)
Treatment groups
1,111 Participants
are divided into 1 treatment groupGroup A: scaffold1 intervention
Trial outcomes
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
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov