Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05786131
  4. Details
NCT05786131 Clinical Trial

Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI

Multivessel Coronary Artery Disease Clinical Trial

— CompleteNSTEMI  

Official title:
Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05786131
Other study ID # 2023-019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 27, 2023
Est. completion date July 31, 2027

Study information
Verified date March 2024
Source Leipzig Heart Science gGmbH
Contact Holger Thiele, MD, Prof. Dr.
Phone +49 341 865-252025
Email holger.thiele@medizin.uni-leipzig.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective, randomized, controlled, multicenter, open-label trial to study whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease.

Description:

The complete revascularization versus culprit lesion only PCI in NSTEMI (COMPLETE-NSTEMI) trial aims to investigate whether multivessel complete PCI is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel coronary artery disease.

Recruitment information / eligibility
Status Recruiting
Enrollment 3390
Est. completion date July 31, 2027
Est. primary completion date January 31, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - NSTEMI as suggested by high-sensitivity troponin algorithms - Multivessel coronary artery disease - Identifiable culprit lesion - Informed consent Exclusion Criteria: - Age <18 years - Cardiogenic shock - Sustained ventricular tachycardia (VT) or ventricular fibrillation (VF) - Contraindication for coronary revascularization - Prior coronary artery bypass graft - Indication for coronary artery bypass graft surgery - Co-morbidity with life expectancy less than 6 months - Type 2 myocardial infarction

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Culprit-lesion revascularization
Percutaneous coronary intervention of culprit-lesion
• Non-culprit-lesion revascularization
Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions

Locations
Country Name City State
Germany Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum Berlin
Germany University Medical Center Göttingen, Department of Cardiology and Pneumology, Georg-August University Göttingen
Germany Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology Leipzig
Germany Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologiy Leipzig

Sponsors (5)
Lead Sponsor Collaborator
Leipzig Heart Science gGmbH German Federal Ministry of Education and Research, Heart Center Leipzig at University of Leipzig, IHF GmbH - Institut für Herzinfarktforschung, Stiftung IHF - Institut für Herzinfarktforschung

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction During follow-up (2 years estimated average duration)
Secondary Rate of Cardiovascular death During follow-up (2 years estimated average duration)
Secondary Rate of Rehospitalization for non-fatal myocardial infarction During follow-up (2 years estimated average duration)
Secondary Rate of all-cause death During follow-up (2 years estimated average duration)
Secondary Rate of ischemia-driven revascularization During follow-up (2 years estimated average duration)
Secondary Rate of rehospitalization for heart failure During follow-up (2 years estimated average duration)
Secondary Composite rate of all-cause death, rehospitalization for non-fatal myocardial infarction, or rehospitalization for ischemia-driven revascularization During follow-up (2 years estimated average duration)
Secondary Rate of coronary artery bypass surgery During follow-up (2 years estimated average duration)
Secondary Quality of Life (EQ-5D-5L) European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Score 1-5 for each dimension, 1 means best outcome EQ VAS score between 0 and 100; higher score means better outcome 12 months
Secondary Rate of bleeding 6 months
Secondary Rate of stroke Ischemic and Hemorrhagic 6 months
Secondary Rate of contrast-induced acute kidney injury AKIN grade I-III 6 months
Secondary Rate of coronary procedure-related myocardial infarction 6 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05669222 - The FAVOR V AMI Trial N/A
Not yet recruiting NCT06025071 - Residual Inflammatory Risk-Guided colcHicine in Elderly Trial Phase 4
Recruiting NCT06168305 - Safety and Effectiveness of GENOSS DES in Patients With Multivessel Coronary Artery Disease
Not yet recruiting NCT05835167 - Complete Revascularization Via Inferior Part-sternotomy N/A
Completed NCT01881555 - Functional Testing Underlying Coronary Revascularisation N/A
Active, not recruiting NCT01621438 - Clinical Implication of 3-vessel Fractional Flow Reserve (FFR) N/A
Not yet recruiting NCT06378775 - Robotically-assisted Minimally-invasive Direct Coronary Artery Bypass With Stenting, Randomized Against Coronary Artery Bypass Graft Surgery N/A
Completed NCT05125367 - Ten-Year Outcomes of Randomized Comparison of Coronary Artery Bypass Surgery and Everolimus-Eluting Stent Implantation in the Treatment of Patients With Multivessel Coronary Artery Disease
Completed NCT01947439 - Comparison of the Biolimus A9-eluting Stent With the Zotarolimus -Eluting Stent in Multi-vessel PCI N/A
Recruiting NCT05333068 - COMBINE-INTERVENE: COMBINEd Ischemia and Vulnerable Plaque Percutaneous INTERVENtion to Reduce Cardiovascular Events N/A
Withdrawn NCT03851276 - A Multicentre, Pilot Study to Evaluate the Safety and the Feasibility of Planning and Execution of Surgical Revascularization in Patients With Complex Coronary Artery Disease, Based Solely on MSCT Imaging Utilizing GE Healthcare Revolution CT and HeartFlow FFRCT. Phase 4
Completed NCT02813473 - SYNTAX III REVOLUTION Trial: A Randomized Study Investigating the Use of CT Scan and Angiography of the Heart to Help the Doctors Decide Which Method is the Best to Improve Blood Supply to the Heart in Patients With Complex Coronary Artery Disease
Recruiting NCT05698719 - Validation of vFFR as Compared to FFR to Guide Revascularization of Non-culprit Lesions in STEMI Patients
Completed NCT01399736 - Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD. N/A
Not yet recruiting NCT01311323 - Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease N/A
Completed NCT00818792 - Randomized Comparison of xiEnce and visioN Coronary Stents in the sAme muLtivessel Patient With Chronic kiDnEy diSease Phase 2
Completed NCT01199419 - Cost-effectiveness of PCI With Taxus vs CABG - 5 Years FUP N/A
Completed NCT04743154 - In-hospital Versus After-discharge Complete Revascularization N/A
Terminated NCT02334826 - Revascularization With BVS or CABG in Patients With Advanced CAD Phase 4
Recruiting NCT04811586 - Efficacy and Safety of One-Stage Hybrid Coronary Revascularization N/A