NCT05230446Recruiting
PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlusions
Source: ClinicalTrials.gov · Last updated 9 Feb 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 609 (estimated)
- First submitted
- 23 Nov 2021
- Start date
- 18 Nov 2021
- Primary completion date
- 18 Nov 2023
- Lead sponsor
- Erasmus Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT05230446
What you commit to
- Study type: Interventional
- Planned participants: 609
- From 18 Nov 2021 to the primary completion date, 18 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Enrollment in another study with another investigational device or drug trial that has not reached the primary endpoint. The patient may only be enrolled once in the PRESENT study.
- Previous coronary artery bypass grafting (CABG).
- Women of childbearing potential who do not have a negative pregnancy test result within 7 days before the procedure, women who are known to be pregnant, or who are breastfeeding.
Other illness
- Single coronary vessel disease.
- Presence of a chronic total occlusion (CTO) defined as coronary lesion with Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 on initial angiography present for more than or equal to 3 months.
- Left main coronary artery disease
- Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to any of the study medications, including both aspirin and P2Y12 inhibitors.
- Patient requiring additional cardiac surgery within 6 months.
Age
- Age \<18 years and \> 85 years.
Other
- No left anterior descending lesion.
- Patients in cardiogenic shock.
- Patients with STEMI.
- Patients who cannot give informed consent or have a life expectancy of less than 12 months.
- Patients with an extreme LAD tortuosity imparing OCT catheter advancement
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Erasmus Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.