Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02870140
Other study ID # ECRI-007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 21, 2016
Est. completion date August 26, 2020

Study information

Verified date December 2020
Source ECRI bv
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to compare the performance of SUPRAFLEX to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.


Description:

This is a prospective, randomized, 1:1 balanced, controlled, single-blind, multi-center study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in a "Real world, all comers" patient population (patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions). The objective is to compare the SUPRAFLEX SES with the XIENCE EES with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real world" patient population. All patients will be (at minimum) contacted at 30 days, 6 months, and 12 months post procedure to assess clinical status and adverse events. The 30 day and 12 month will be a clinic visit. All patients will have annual contact through 3 years follow-up to assess clinical status and adverse events.


Recruitment information / eligibility

Status Completed
Enrollment 1435
Est. completion date August 26, 2020
Est. primary completion date September 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: All comers" patients: - Male or female patients 18 years or older; - Presence of one or more coronary artery stenoses of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. - The vessel should have a reference vessel diameter ranging from =2.25 mm to =4.5 mm (no limitation on the number of treated lesions, vessels, or lesion length); All lesions of the patient must comply with the angiographic inclusion criteria. - The patient (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed. Patient is willing to comply with all protocol-required evaluations. Exclusion Criteria: - Known pregnancy or breastfeeding at time of randomization; - Known contraindication or hypersensitivity to sirolimus, everolimus, cobalt-chromium, or to medications such as aspirin, heparin, bivalirudin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor; - Any PCI treatment within 6 months (<6 months) prior to the index procedure. - Concurrent medical condition with a life expectancy of less than 12 months. - The patient is unwilling/ not able to return for outpatient clinic at 12 months follow-up. - Currently participating in another trial and not yet at its primary endpoint.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
SUPRAFLEX
Percutaneous Coronary Intervention
XIENCE
Percutaneous Coronary Intervention

Locations

Country Name City State
Bulgaria Research Centre BG-004 Plovdiv
Bulgaria Research Centre BG-001 Sofia
Hungary Research Centre HU-002 Budapest
Hungary Research Centre HU-001 Szeged
Italy Research Centre IT-001 Milan
Netherlands Research Centre NL-007 Amsterdam
Netherlands Research Centre NL-008 Breda
Netherlands Research Centre NL-009 Eindhoven
Netherlands Research Centre NL-002 Leeuwarden
Netherlands Research Centre NL-003 Rotterdam
Poland Research Centre PL-002 Chrzanow
Poland Research Centre PL-005 Kedzierzyn- Kozle
Poland Research Centre NL-009 Warsaw
Spain Research Centre ES-003 Barcelona
Spain Research Centre ES-005 Barcelona
Spain Research Centre ES-012 Madrid
Spain Research Centre ES-018 Vigo
United Kingdom Research Centre GB-021 Belfast
United Kingdom Research Centre GB-002 Cardiff
United Kingdom Research Centre GB-010 Cottingham
United Kingdom Research Centre GB-022 London
United Kingdom Research Centre GB-013 Newcastle-Upon-Tyne
United Kingdom Research Centre GB-012 Stevenage

Sponsors (2)

Lead Sponsor Collaborator
ECRI bv Sahajanand Medical Technologies Pvt. Ltd.

Countries where clinical trial is conducted

Bulgaria,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Non inferiority comparison of a device oriented composite endpoint (DOCE) or Target Lesion Failure (TLF) of the SUPRAFLEX group to the XIENCE group TLF is a composite of clinical endpoint of cardiac death, target vessel myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization. 12 months post-procedure
Secondary Patient Oriented Composite Endpoint (PoCE) defined as the composite of all-cause death, any MI, and any revascularization 30 days, 6 months, 1 year, 2 years and 3 years
Secondary Target Vessel Failure (TVF) defined as cardiac death, TV MI, and clinically indicated target vessel revascularization 30 days, 6 months, 1 year, 2 years and 3 years
Secondary TLF (DoCE) defined as cardiac death, TV MI and clinically-indicated target lesion revascularization (for all follow-up/visits other than 12 months) 30 days, 6 months, 1 year, 2 years and 3 years
Secondary Mortality (All death, Cardiac death, and Non-cardiac death (vascular and non-cardiovascular) 30 days, 6 months, 1 year, 2 years and 3 years
Secondary Myocardial Infarction (All MI, Target Vessel MI, Non-Target Vessel MI) 30 days, 6 months, 1 year, 2 years and 3 years
Secondary Revascularization (Any revascularisation, TLR (clinically and non-clinically), TVR (clinically and non-clinically) and non-TVR. 30 days, 6 months, 1 year, 2 years and 3 years
Secondary Stent thrombosis rates according to ARC classification 30 days, 6 months, 1 year, 2 years and 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT03427996 - Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice
Terminated NCT03175523 - HOW To Optimally Implant BioResorbable Scaffold - Intravascular Imaging Versus Quantitative Coronary Angiography Guidance N/A
Active, not recruiting NCT04475380 - Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
Completed NCT01184183 - Trial Comparison of Accuseal and Bovine Pericardial Patch During Endarterectomy
Completed NCT00697372 - SEA-SIDE: Sirolimus Versus Everolimus-eluting Stent Randomized Assessment in Bifurcated Lesions and Clinical SIgnificance of Residual siDE-branch Stenosis Phase 4
Completed NCT05509296 - Compare the Effectiveness and Safety of Two Different Kinds of Cutting Balloon in Coronary Artery Disease N/A
Recruiting NCT03054324 - Validation of a Predictive Model of Coronary Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
Enrolling by invitation NCT06194526 - Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography
Not yet recruiting NCT06039748 - Angiography-Derived Quantitative Functional Assessment Versus Pressure-Derived FFR and IMR: The FAIR Study
Not yet recruiting NCT05753085 - Multimodality Optical and Ultrasound Intravascular Imaging for Stent Optimization and Atheroma Assessment N/A
Not yet recruiting NCT05471687 - Evaluation of the Functional Impact of Coronary Stenoses in Diabetics by Spectral CT N/A
Not yet recruiting NCT04569669 - The Sensitivity and Specificity of CardioSimFFRct Analysis Software on Coronary Artery Stenosis N/A
Active, not recruiting NCT02508714 - Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents N/A
Completed NCT03301246 - Artimes Pro Low Profile Dilatation Catheters for Pre-Dilatation in Patients With Symptomatic Ischemic Heart Disease N/A
Completed NCT03606330 - Systemic, Pancoronary and Local Coronary Vulnerability
Not yet recruiting NCT06071702 - IonMAN II Trial- Early Feasibility Study of the IoNIR Ridaforolimus-Eluting Coronary Stent System N/A
Completed NCT02275143 - Computed Tomography (CT) Coronary Angiogram Evaluation in Cancer Patients Having CT Thorax, Abdomen and Pelvis N/A
Active, not recruiting NCT01794065 - The Promus Element Rewards Study N/A
Completed NCT02120859 - Optical Coherence Tomography to Investigate FFR-Guided DEB-only Elective Coronary Angioplasty Phase 4