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

NCT05104580 | Unknown

• 1 other identifier: ZS-20211021
• Study Type: observational
• Target: 1,395
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cardiac death or vessel-related MI

  at 2 years from index procedure

• Vessel-related MI

  at 2 years from index procedure

• Cardiac death

  at 2 years from index procedure

• Ischemia-driven target vessel revascularization

  at 2 years from index procedure

Study Arms (3)

Group 1

High pre-PCI PPG index and high post-PCI QFR

Device: Quantitative Flow Ratio derived PPG

Group 2

Low pre-PCI PPG index and high post-PCI QFR

Device: Quantitative Flow Ratio derived PPG

Group 3

Low post-PCI QFR regardless of pre-PCI PPG index

Device: Quantitative Flow Ratio derived PPG

Interventions

Quantitative Flow Ratio derived PPG DEVICE

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.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1,395 patients with 1,685 target vessels with measurable QFR and PPG index from the PANDA-III study (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice) (NCT02017275).

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Related Publications (4)

• 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.

  PMID: 27173037 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

• 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. 2022 Jan 1;99(1):E12-E21. doi: 10.1002/ccd.29983. Epub 2021 Oct 15.

  PMID: 34652068 BACKGROUND

• Dai N, Yuan S, Dou K, Zhang R, Hu N, He J, Guan C, Zou T, Qiao Z, Duan S, Xie L, Yu Y, Zhang Y, Xu B, Ge J. Prognostic Implications of Prestent Pullback Pressure Gradient and Poststent Quantitative Flow Ratio in Patients Undergoing Percutaneous Coronary Intervention. J Am Heart Assoc. 2022 Jun 7;11(11):e024903. doi: 10.1161/JAHA.121.024903. Epub 2022 Jun 3.

  PMID: 35656982 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Junbo Ge, Professor

  Fudan University

  STUDY CHAIR

• Bo Xu, MBBS

  Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neng Dai, MD

CONTACT

+8613701997266; niceday1987@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 3, 2021
• Study Start: October 30, 2021
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: November 3, 2021

Record last verified: 2021-10