PrOgnostic Implications of PRe-stent Pullback Pressure GradIent and Post-stent Quantitative Flow Ratio in Patients UnderGoing Percutaneous Coronary INtervention

Coronary Artery Disease Clinical Trial

— CHART-ORIGIN  

Official title:

PrOgnostic Implications of PRe-stent Pullback Pressure GradIent and Post-stent Quantitative Flow Ratio in Patients UnderGoing Percutaneous Coronary INtervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05104580
• Other study ID #: ZS-20211021
• Status: Not yet recruiting
• Start date: October 30, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: October 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Neng Dai, MD
• Phone: +8613701997266
• Email: niceday1987[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the prognostic implication of pre-percutaneous coronary intervention (PCI) focal or diffuse disease patterns combined with post-PCI quantitative flow ratio (QFR).

Description:

Coronary diffuse disease associates with poor outcomes, but little is known about whether this prognostic value retains after PCI, especially in those with good post-PCI physiologic results.

QFR can provide the virtual pullback curve by depicting pressure at each point along the interrogated vessel, which can be used to calculate the pullback pressure gradient (PPG) index, this index has been shown to be able to suggest the physiological plaque distribution and to discriminate focal from diffuse disease. Absolute quantification of coronary diffuseness makes it possible to evaluate the prognostic value of baseline coronary diffuseness before stent implantation, which is rarely investigated till now.

The CHART-ORIGIN study aims to investigate the independent and additive prognostic implications of pre-PCI functional disease patterns assessed by PPG with post-PCI QFR in vessels with stent implantation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1395
• Est. completion date: March 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with at least one vessel with measurable QFR

• PPG index can be calculated from virtual QFR pullback curve;

• The patient is willing to comply with specified follow-up evaluations;

• Patients who agree to accept the follow-up visits.

Exclusion Criteria:

• Culprit vessels for ACS myocardial infarction;

• Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;

• Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);

• Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated;

• Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;

• Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Quantitative Flow Ratio derived PPG
From coronary angiographic images, QFR will be calculated and virtual pullback curve will be abstracted and PPG index will be calculated as: PPG index={MaxPPG20mm/?QFRvessel+(1-length with functional disease/Total vessel length) }/2.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Chinese Academy of Medical Sciences, Fuwai Hospital

References & Publications (3)

Dai N, Hwang D, Lee JM, Zhang J, Jeon KH, Paeng JC, Cheon GJ, Koo BK, Ge J. Feasibility of Quantitative Flow Ratio-Derived Pullback Pressure Gradient Index and Its Impact on Diagnostic Performance. JACC Cardiovasc Interv. 2021 Feb 8;14(3):353-355. doi: 10.1016/j.jcin.2020.10.036. Erratum in: JACC Cardiovasc Interv. 2021 Sep 13;14(17):1963. — View Citation

Dai N, Zhang R, Hu N, Guan C, Zou T, Qiao Z, Zhang M, Duan S, Xie L, Dou K, Zhang Y, Xu B, Ge J. Integrated coronary disease burden and patterns to discriminate vessels benefiting from percutaneous coronary intervention. Catheter Cardiovasc Interv. 2021 Oct 15. doi: 10.1002/ccd.29983. [Epub ahead of print] — View Citation

Xu B, Gao R, Yang Y, Cao X, Qin L, Li Y, Li Z, Li X, Lin H, Guo Y, Ma Y, Wang J, Nie S, Xu L, Cao E, Guan C, Stone GW; PANDA III Investigators. Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial. J Am Coll Cardiol. 2016 May 17;67(19):2249-2258. doi: 10.1016/j.jacc.2016.03.475. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vessel-oriented composite outcome	Vessel-oriented composite outcome (VOCO) including vessel related ischemia-driven target vessel revascularization, vessel-related myocardial infarction (MI), and cardiac death.	at 2 years from index procedure
Secondary	Cardiac death or vessel-related MI	Cardiac death or vessel-related MI	at 2 years from index procedure
Secondary	Vessel-related MI	Vessel-related MI	at 2 years from index procedure
Secondary	Cardiac death	Cardiac death	at 2 years from index procedure
Secondary	Ischemia-driven target vessel revascularization	Ischemia-driven target vessel revascularization	at 2 years from index procedure