---
title: Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention
nct_id: NCT01873560
overall_status: COMPLETED
sponsor: Inje University
study_type: OBSERVATIONAL
primary_condition: Coronary Disease
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01873560.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01873560"
ct_last_update_post_date: 2023-09-28
last_seen_at: "2026-05-12T06:09:46.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention

**Official Title:** Influence of Fractional Flow Reserve (FFR) on the Clinical OutcomEs of PERcutaneouS Coronary Intervention (PCI): A ProspECTIVE, Multicenter FFR Registry

**NCT ID:** [NCT01873560](https://clinicaltrials.gov/study/NCT01873560)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 1250
- **Lead Sponsor:** Inje University
- **Collaborators:** Seoul National University Hospital, Keimyung University Dongsan Medical Center, Ulsan University Hospital, Busan Veterans General Hospital, Samsung Medical Center, Sejong General Hospital, Tokyo Medical University, Gifu Heart Center, Japanese Red Cross Kyoto Daini Hospital
- **Conditions:** Coronary Disease
- **Start Date:** 2013-05
- **Completion Date:** 2016-12
- **CT.gov Last Update:** 2023-09-28

## Brief Summary

Fractional flow reserve (FFR) is a physiologic index for the determination of ischemia-causing coronary stenosis as well as drug eluting stent (DES) optimization, even multiple anatomic imaging parameters have been widely used in clinical practice for the assessment of optimal stent procedure. Prognostic value of post-stent FFR (FFRpost) have been rarely evaluated in patient treated with 2nd generation DES. This multicentre, prospective registry was aimed to evaluate the influence of physiologic parameters on the clinical outcome after 2nd generation DES implantation.

## Detailed Description

Patients who diagnosed obstructive coronary artery disease and treated by DES with FFR examination would be enrolled, consecutively. FFR measurement would be required at the baseline and at the end of index PCI procedure. PCI procedure would be performed upon local routine. Any available 2nd generation DES could be used. Informed consent should be obtained and protocol should be approved by each collaborator's institutional review board (IRB). Web-based electronic-case record form (CRF) system will be used for collecting data. All data will be handled and analyzed by blind fashion at independent core lab. Patient will be followed-up at each collaborator's hospital at least 2 year after index procedure. Any adverse event will be reported and addressed immediately by appropriate medical treatment to protect patient.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* any patient meets eligible criteria who underwent PCI with DES followed by FFR measurement at the index procedure
* patient who provide informed consent

Exclusion Criteria:

* 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 stenosis
* primary myocardial or valvular heart disease
* in patient whose life expectancy less than 2 years
* visible thrombus of target vessel segment
```

## Arms

- **FFRpost** — High FFRpost group and low FFRpost group were defined according to the optimal cut-off value for predicting clinical outcome.

## Primary Outcomes

- **Target-vessel failure** _(time frame: 2 years after index procedure)_ — During two-year follow-up period, target-vessel failure (composite of cardiac death, target-vessel related myocardial infarction, and clinically-driven target vessel revascularization) will be evaluated. Target vessel will be defined as the treated vessel with DES which assessed by post-stent FFR.

All clinical outcome will be reported according to the location of target vessel (LAD vs. non-LAD).

## Secondary Outcomes

- **clinical, angiographic and physiologic predictors for target-vessel failure** _(time frame: 2 years after index procedure)_

## Locations (4)

- Inje University Ilsan Paik Hospital, Goyang-si, Gyeonggi-do, South Korea
- Keimyung University Dongsan Medical Center, Daegu, South Korea
- Seoul National University Hospital, Seoul, South Korea
- Ulsan University Hospital, Ulsan, South Korea

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.inje university ilsan paik hospital|goyang-si|gyeonggi-do|south korea` — added _(2026-05-12)_
- `locations.keimyung university dongsan medical center|daegu||south korea` — added _(2026-05-12)_
- `locations.seoul national university hospital|seoul||south korea` — added _(2026-05-12)_
- `locations.ulsan university hospital|ulsan||south korea` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01873560*  
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