Physio PCI: Impact of Coronary Angioplasty on Non-hyperaemic Pressure

Status Terminated

Clinical Trial Summary

The use of intra coronary physiological assessment with fractional flow reserve (FFR) is nowadays the standard approach to define ischemia-inducing stenosis and guide myocardial revascularization strategy in patients with coronary artery disease. Further, FFR has been shown to be a strong and independent predictor of major adverse cardiac events after stent implantation. A lower value of FFR after stent implantation is associated with a worse clinical prognosis, without a clearly defined threshold above which clinical follow up are similar for all FFR values. Among 750 patients in the Fractional Flow Reserve Post-Stent Registry, the event rate was 29.5% in patients with FFR<0.80 compared to 9 4.9% in patients with FFR>0.95 (p<0.001). However, FFR remains poorly adopted in many cathlabs, partly because of procedural time, discomfort or sides effect during hyperemia, non-uniform adenosine response and economical constraints. This leads to the validation of resting indices (instantaneous wave-free ratio (iFR), diastolic pressure ratio (dPR), and resting full-cycle ratio (RFR) among others). Those indices evaluate coronary physiology without the use of maximal hyperemia and have 15 slightly different threshold compared to FFR (≤0.89 vs 0.80, for iFR and RFR, and FFR 16 respectively).In the VALIDATE RFR study, a head-to-head comparison of RFR and iFR from a retrospective analysis, diagnostic accuracy of RFR was 97.4% with an area under the curve 1 (AUC) of 99.6%. In the more recent RE-VALIDATE RFR study, 431 patients with 501 lesions 2 were prospectively evaluated for the diagnostic performance of RFR in all-comers patients. Compared to iFR, RFR achieved high diagnostic accuracy, sensitivity and specificity. These are the reasons why we designed a prospective, non-randomized, clinical trial, to better 18 explore the value of RFR before and after PCI in real live and after optimization by post dilation 19 in all-comers patients with coronary artery disease in the Middle East region..

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04679805
Study type	Observational
Source	Ceric Sàrl
Contact
Status	Terminated
Phase
Start date	June 6, 2021
Completion date	July 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06030596` - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed	`NCT04080700` - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting	`NCT03810599` - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study	N/A
Recruiting	`NCT06002932` - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.	N/A
Not yet recruiting	`NCT06032572` - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)	N/A
Recruiting	`NCT05308719` - Nasal Oxygen Therapy After Cardiac Surgery	N/A
Recruiting	`NCT04242134` - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions	N/A
Completed	`NCT04556994` - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.	N/A
Recruiting	`NCT05846893` - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease	N/A
Recruiting	`NCT06027788` - CTSN Embolic Protection Trial	N/A
Recruiting	`NCT05023629` - STunning After Balloon Occlusion	N/A
Completed	`NCT04941560` - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed	`NCT04006288` - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease	Phase 4
Completed	`NCT01860274` - Meshed Vein Graft Patency Trial - VEST	N/A
Recruiting	`NCT06174090` - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients	N/A
Completed	`NCT03968809` - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated	`NCT03959072` - Cardiac Cath Lab Staff Radiation Exposure
Recruiting	`NCT04566497` - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.	N/A
Recruiting	`NCT05065073` - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography	Phase 4
Completed	`NCT05096442` - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Physio PCI: Impact of Coronary Angioplasty on Non-hyperaemic Pressure Ratio in Patients With Coronary Artery Disease

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms