Angiography-derived FFR GPS in Predicting Post-PCI Physiological and Clinical Outcomes

NCT05496023 | Unknown

• 2 other identifiers: ZS20220808CHART2022-04
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the feasibility of physiological map generated from angiography-derived fractional flow reserve (FFR) (angio-FFR) pullback and its value in predicting physiological and clinical outcomes after stenting.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (3)

• Propotion of angio-FFR based physiological map successfully created

  Propotion of successful angio-FFR based physiological map created by overlaying the angio-FFR based pullback onto coronary angiogram will be calculated

  Immediate after angiography

• Correlation of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI

  Pearson Correlation analysis will be performed to assess the correlation of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI

  Immediate post-PCI

• Agreement of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI

  Bland-altman analysis will be performed to assess the agreement of predicted post-PCI angio-FFR by physiological map with angio-FFR after PCI

  Immediate post-PCI

Secondary Outcomes (7)

• Correlation of pre-PCI angio-FFR with pre-PCI FFR

  Immediate after pre-PCI FFR measurement

• Agreement of pre-PCI angio-FFR with pre-PCI FFR

  Immediate after pre-PCI FFR measurement

• Correlation of post-PCI angio-FFR with post-PCI FFR

  Immediate post-PCI FFR measurement

• Agreement of post-PCI angio-FFR with post-PCI FFR

  Immediate post-PCI FFR measurement

• Correlation of pre-PCI angio-FFR derived pullback pressure gradient (PPG) with post-PCI angio-FFR

  Immediate post-PCI

Study Arms (2)

Pre PCI state

The current study will analyze the angio-FFR and generate the virtual pullback. The pullback will be co-registered by overlaying the pullback onto coronary angiogram.

Device: Percutaneous coronary intervention

Post-PCI state

The post-PCI FFR and angio-FFR will be meaured.

Interventions

Percutaneous coronary intervention DEVICE

1. Pre-PCI angio-FFR was calculated and virtual pullback was generated 2. Automated algorithm to calculate delta angio-FFR per unit length and co-registered onto coronary angiogram was developed 3. PCI was performed using 2nd generation DES

Pre PCI state

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who diagnosed obstructive coronary artery disease and evaluated by pre-PCI FFR measurement, then treated by DES with invasive physiologic evaluation at the index procedure.

You may qualify if:

• any patient meets eligible criteria who underwent PCI with DES followed by invasive physiologic assessment at the index procedure
• any patient who underwent PCI for lesions with pre-PCI FFR\<=0.80
• available of both pre- and post-PCI FFR measurement
• available of both pre- and post-PCI angio-FFR calculation
• available of pre-PCI co-registration of angio-FFR with coronary angiogram

You may not qualify if:

• unavailable pre-PCI angio-FFR calculation and co-registration with coronary angiogram
• unavailable post-PCI angio-FFR calculation
• culprit vessel of acute coronary syndrome
• failed achieving TIMI 3 flow at the end of PCI
• left ventricular ejection fraction \<30%
• graft vessel
• collateral feeder
• in-stent restenosis
• primary myocardial or valvular heart disease
• in patient whose life expectancy less than 2 years
• visible thrombus of target vessel segment

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital of Fudan University

Shanghai, 200032, China

RECRUITING

Related Publications (3)

• Dai N, Che W, Liu L, Zhang W, Yin G, Xu B, Xu Y, Duan S, Yu H, Li C, Yao K, Huang D, Ge J. Diagnostic Value of Angiography-Derived IMR for Coronary Microcirculation and Its Prognostic Implication After PCI. Front Cardiovasc Med. 2021 Oct 15;8:735743. doi: 10.3389/fcvm.2021.735743. eCollection 2021.

  PMID: 34722667 BACKGROUND

• Shin D, Dai N, Lee SH, Choi KH, Lefieux A, Molony D, Hwang D, Kim HK, Jeon KH, Lee HJ, Jang HJ, Ha SJ, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Doh JH, Shin ES, Nam CW, Koo BK, Gwon HC, Ge J, Lee JM. Physiological Distribution and Local Severity of Coronary Artery Disease and Outcomes After Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2021 Aug 23;14(16):1771-1785. doi: 10.1016/j.jcin.2021.06.013.

  PMID: 34412795 BACKGROUND

• 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. No abstract available.

  PMID: 33541549 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Junbo Ge, MD

  Fudan University

  STUDY CHAIR

Central Study Contacts

Neng Dai, MD

CONTACT

+8613701997266; niceday1987@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 10, 2022
• Study Start: January 1, 2017
• Primary Completion: August 30, 2022
• Study Completion: October 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

CN (1)