PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This prospective, multicenter, non-randomized, single arm, objective performance goal (OPG) study is designed to evaluate clinical outcomes after complete revascularization by PCI and imaging guidance (OCT) in patients with multivessel coronary artery disease including left anterior descending (LAD) presenting with stable angina, or documented silent ischemia, or non-ST segment elevation acute coronary syndrome (NSTE-ACS).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Age ≥ 18 years, ≤85 years

• The patient is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki

• Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Instructions for Use' that comes with every Resolute Onyx (Zotarolimus-Eluting stent) system.

• The patient is willing and able to cooperate with study procedures and required follow up visits

• The subject or legal representative has been informed of the nature of the study and agrees to its provisions and has provided an EC approved written informed consent, including data privacy authorization

Locations
Other Locations
Netherlands
Erasmus Medical Center
RECRUITING
Rotterdam
Contact Information
Primary
Roberto Diletti, MD PhD
r.diletti@erasmusmc.nl
+31 (0)10 70 352 60
Backup
Hala Kakar, MD
h.kakar.1@erasmusmc.nl
Time Frame
Start Date: 2021-11-18
Estimated Completion Date: 2027-11-18
Participants
Target number of participants: 609
Treatments
Other: Percutaneous Coronary Intervention
Interventional comparitor, compared to an optimal performance goal of 7% MACCE resulted from past CABG results
Sponsors
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov