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

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Fudan University

Status

Enrolling

Conditions

Coronary Artery Disease

Treatments

Device: Percutaneous coronary intervention

Study type

Observational

Funder types

Other

Identifiers

NCT05496023
CHART2022-04 (Registry Identifier)
ZS20220808

Details and patient eligibility

About

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.

Full description

Physiological coronary lesion evaluation such as fractional flow reserve (FFR) is now recommended by guidelines to guide percutaneous coronary intervention (PCI). However, it was not widely used in subsequent years for a variety of reasons, including the additional time needed to measure pressure wire-derived FFR, technical challenges and the small risk associated with maneuvering a pressure wire down a coronary artery, the added time to assess multiple vessels, issues with drift in the pressure wire reading, and the time, expense, and associated side effects with some hyperemic agents necessary to measure FFR. In recent years, advancements in technology made it possible to calculate FFR from conventional coronary angiography without the need of a pressure wire or hyperemic agent. The FAVOR III (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous InterVention in Patients With cORonary Artery Disease) China has demonstrated that angiography-derived FFR (angio-FFR) improved outcomes for PCI compared with a standard angiography-guided strategy. Like FFR, angio-FFR is also performed in a binary manner to determine whether a vessel requires intervention and does not automatically indicate the haemodynamic improvement that would be expected post stenting. However, one advantage of angio-FFR is that virtual pullback could be generated during its calculation. Most importantly, though hyperemic blood flow was applied in angio-FFR calculation, it was predicted from resting flow with mathematical algorithm. As resting flow is more constant, consistent, and predictable across different stenoses, then resting pressure changes measured along the length of a vessel will be more predictable. Using this property, a physiological vessel map could be produced with angio-FFR by co-registration the pullback onto coronary angiogram, which not only highlight functional significant lesions and lesion locations, but also offer the possibility of prospective simple computerized virtual PCI to assess the potential hemodynamic impact before actual stent implantation. In this regard, the investigators aim to calculate angio-FFR and to develop an angio-FFR pullback. And the investigators hypothesize that angio-FFR-derived pullback would be possible to produce a physiological map showing lesion severity and location, in addition, it could be used to perform virtual PCI and predict the physiological impact of stenting; the physiological map could be used to measure physiological lesion length and intensity.

Enrollment

329 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

329 participants in 2 patient groups

Pre PCI state
Description:
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.
Treatment:
Device: Percutaneous coronary intervention
Post-PCI state
Description:
The post-PCI FFR and angio-FFR will be meaured.

Trial contacts and locations

0

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Central trial contact

Neng Dai, MD

Data sourced from clinicaltrials.gov

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