Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04098172
Other study ID # S2434
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2019
Est. completion date March 11, 2020

Study information

Verified date May 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire Certus® in FFR measurements


Description:

The COMET China study is a prospective, open-label, multi-center study designed to validate the agreement of CometTM Pressure Guidewire and Pressure Wire CertusĀ® in FFR measurements. Patient with stable angina or any form of non-ST elevation acute coronary syndrome, who are scheduled for diagnostic angiography and pressure wire assessment, and signed the informed consent, will be screened for enrollment in this study.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date March 11, 2020
Est. primary completion date March 11, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility General Inclusion Criteria: 1. Patient must be at least 18 years old and less than or equal to 75 years of age 2. Patient or his/her legally-authorized representative agrees to sign the EC-approved ICF prior to the procedure 3. Patient with stable angina or any form of non-ST elevation acute coronary syndrome and is clinically indicated of intra-coronary diagnostic angiography and FFR assessment Angiographic Inclusion Criteria: Moderate stenosis (30% to 70% diameter stenosis by visual estimation) is detected at diagnostic angiography General Exclusion Criteria: 1. Patients unable to provide informed consent 2. Patients in pregnant state 3. Known renal insufficiency or failure (serum creatinine level of > 2.5 mg/dL, or on dialysis) 4. Allergy to the contrast 5. Significant arrhythmia, such as II degree or above of atrioventricular block, Sick sinus syndrome, ventricular tachycardia 6. Spastic bronchial asthma 7. ST elevation coronary syndrome 8. Hemodynamic instability 9. Contraindication to nitroglycerin or ATP 10. Current participation in another investigational drug or device clinical study that may affect the FFR measurements Angiographic Exclusion Criteria: CTO lesion Severe vessel tortuosity at the stenotic segments Culprit vessel of non-ST-segment elevation acute myocardial infarction

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pressure Guidewire
Fractional Flow Reserve measurement

Locations

Country Name City State
China The General Hospital of Tianjin Medical University Tianjin Tianjin
China The First Affilited Hospital of Xi,an Jiaotong University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fractional Flow Reserve (FFR) All eligible subjects will receive FFR measurements simultaneously by both CometTM Pressure Guidewire and Pressure wires CertusĀ®. Fractional flow reserve (FFR) measurement involves determining the ratio between the maximum achievable blood flow in a diseased coronary artery and the theoretical maximum flow in a normal coronary artery. An FFR of 1.0 is widely accepted as normal. An FFR lower than 0.75-0.80 is generally considered to be associated with myocardial ischemia (MI).
Agreement between the method of measurement will be confirmed if both conditions are met:
The mean paired difference is within +/- 0.005
during procedure, 1 hour
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Recruiting NCT04417387 - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting NCT06211361 - Cardiac Rehabilitation Program in Patients With Cardiovascular Disease N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04514445 - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Completed NCT03680638 - The Effect of Antioxidants on Skin Blood Flow During Local Heating Phase 1
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Completed NCT04083872 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting) Phase 1
Completed NCT04083846 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed) Phase 1
Completed NCT03693365 - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed NCT03466333 - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia Phase 2
Completed NCT03619148 - The Incidence of Respiratory Symptoms Associated With the Use of HFNO N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT05132998 - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)