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Impact of Dynamic CoROnary RoADmap System for Guidance of Instantaneous Wave-Free Ratio or Fractional Flow Reserve: A Single-Center, Randomized Study

Impact of Dynamic CoROnary RoADmap System for Guidance of Instantaneous Wave-Free Ratio or Fractional Flow Reserve: A Single-Center, Randomized Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008069
Enrollment
226
Registered
2023-01-02
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : A single-institution randomized study, the study will be conducted in 226 patients with 50% to 90% of coronary artery stenosis on angiography. Then randomly assigned, 115 patients

Sponsors

Yonsei University Yongin Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) patient aged 19 or over (2) Patients with 50-90% stenosis of the causative blood vessels undergoing coronary angiography with stable angina including asymptomatic ischemic heart disease (3) patient with 50-90% stenosis of non-genuine blood vessels that are multi-vascular diseases and did not cause acute coronary syndrome in patients with acute coronary syndrome (4) Patients who arbitrarily decided to participate in this study and agreed in writing to the subject's consent.

Exclusion criteria

Exclusion criteria: (1) patient with acute coronary syndrome and single vascular disease (2) Patients who have previously undergone coronary artery bypass surgery (3) In case the coronary artery blood flow is not smooth (TIMIgrade2)2) (4) Life expectancy is less than 1 year (5) a woman who is pregnant or wishes to become pregnant

Design outcomes

Primary

MeasureTime frame
Time spent by the operator to pass the FFR/iFR pressure line through the lesion and attach it to the distal end of the vessel

Secondary

MeasureTime frame
test success rate;Whether to use contrast until a pressure wire is attached to the tip of the vessel;(3) Amount of contrast medium used until the pressure wire is attached to the end of the blood vessel;(4) Total time required to attach the pressure wire to the end of the blood vessel;(5) Total treatment time;(6) Amount of total contrast medium used;(7) total radiation exposure;(8) Complications associated with surgery

Countries

Korea, Republic of

Contacts

Public ContactKim YongCheol

Yonsei University Yongin Severance Hospital

yongcheol@yuhs.ac+82-31-5189-8967

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026