Clinical Trials Directory

Trials / Completed

CompletedNCT03049657

Efficacy of Angiolite Stent vs a Second-generation Drug-eluting Stent Xience for Percutaneous Coronary Intervention

Randomized Clinical Trial to Compare the Efficacy of Angiolite Stent Versus a Second-generation Drug-eluting Stent Such as Xience in Patients With Indication of Percutaneous Coronary Intervention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
220 (actual)
Sponsor
Cardiva2 S.L. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Clinical trial with an "European Community marked" medical device in patients with ischemic heart disease and clinical indication of coronary revascularization with drug-eluting stent. Clinical follow-up will be done according to this way: first month telephone or face-to-face interview and at 6 ± 1 month an Angiography follow up + OCT (optical coherence tomography) A randomized clinical trial to compare the efficacy of Angiolite Stent versus a second-generation drug-eluting stent such as Xience stent.(non-inferiority design)

Conditions

Interventions

TypeNameDescription
DEVICEAngiolitePercutaneous coronary intervention
DEVICEXiencePercutaneous coronary intervention

Timeline

Start date
2016-02-02
Primary completion
2017-03-31
Completion
2019-01-28
First posted
2017-02-10
Last updated
2019-04-12

Locations

11 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT03049657. Inclusion in this directory is not an endorsement.