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PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX)

Primary Purpose

Coronary Artery Disease, Angina Pectoris

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
OCT-guided PCI
Angiography-guided PCI
Drug-eluting stent
Sponsored by
Chonnam National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Percutaneous Coronary Intervention, Intravascular Imaging, Optical Coherence Tomography, Fractional Flow Reserve, Complex Lesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients >18 years old
  2. Patients with stable or unstable angina and complex coronary lesions*

  3. Patients who were indicated revascularization

    • Diameter stenosis >90% by angiography
    • Diameter stenosis with 50~90% with pre-interventional FFR ≤0.80

  4. Patients who underwent implantation of 2nd generation drug-eluting stent

    • Definitions of complex coronary lesions

      1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size
      2. Chronic total occlusion (≥3 months) as target lesion
      3. PCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)
      4. Long coronary lesions (implanted stent ≥38 mm in length)
      5. Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session)
      6. Multiple stents needed (≥3 more stent per patient)
      7. In-stent restenosis lesion as target lesion
      8. Severely calcified lesion (encircling calcium in angiography)
      9. Left anterior descending (LAD), left circumflex artery (LCX), and right coronary artery (RCA) ostial lesion

Exclusion Criteria:

  1. Target lesions not amenable for PCI by operators' decision
  2. Cardiogenic shock (Killip class IV) at presentation
  3. Less than TIMI 3 flow of target vessel after index procedure
  4. Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus
  5. Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
  6. Renal insufficiency such that an additional contrast medium would be harmful for patient
  7. Recent ST-segment elevation myocardial infarction (STEMI)
  8. Inability to receive adenosine or nicorandil injection
  9. Pregnancy or breast feeding
  10. Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
  11. Unwillingness or inability to comply with the procedures described in this protocol

Sites / Locations

  • Keimyung University Dongsan Hospital
  • Chonnam National University HospitalRecruiting
  • Chung-Ang University Gwangmyeong Hospital
  • Jeju National University Hospital
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

OCT-guided PCI arm

Angiography-guided PCI arm

Arm Description

Use of OCT will be strongly recommended at any step of PCI (pre-PCI, during PCI and post-PCI), but OCT evaluation after stent implantation will be mandatory. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended.

The PCI procedure in this group will be performed as standard procedure. After deployment of stent, stent optimization will be done based on angiographic findings. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended.

Outcomes

Primary Outcome Measures

Suboptimal post-PCI physiological results
Proportion of patients with a final post-interventional fractional flow reserve <0.85

Secondary Outcome Measures

Rate of target vessel failure (TVF)
a composite of cardiac death, target-vessel myocardial infarction (MI), and target-vessel revascularization (TVR)
Rate of all-cause death
death from any-cause
Rate of cardiac death
death from cardiac-cause
Rate of target vessel MI without periprocedural MI
Myocardial infarction without periprocedural myocardial infarction
Rate of target vessel MI with periprocedural MI
Myocardial infarction with periprocedural myocardial infarction
Rate of target lesion revascularization (TLR)
ischemia-driven or all
Rate of target vessel revascularization (TVR)
ischemia-driven or all
Rate of any MI
any myocardial infarction
Rate of any revascularization
ischemia-driven or all
Rate of stent thrombosis
definite, probable, or possible
FFR gain between pre- and post-interventional stages
[Post-interventional fractional flow reserve value] - [Pre-interventional fractional flow reserve value]
Trans-stent FFR gradient
FFR gradient across the stent (ΔFFRstent)
Post-interventional non-hyperemic pressure ratios
Values of post-PCI non-hyperemic pressure ratios

Full Information

First Posted
August 7, 2022
Last Updated
October 16, 2023
Sponsor
Chonnam National University Hospital
Collaborators
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT05493904
Brief Title
PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX)
Official Title
Impact of Optical Coherence Tomography-guided Versus Angiography-guided Stent Optimization on Post-Interventional Fractional Flow Reserve in Patients With Complex Coronary Artery Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chonnam National University Hospital
Collaborators
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to compare post-interventional fractional flow reserve (FFR) value between optical coherence tomography(OCT)-guided and angiography-guided strategy for treatment of complex coronary lesion.
Detailed Description
There has been ample evidence of the role of intracoronary imaging for optimizing the stent, especially among the patients with complex coronary lesions. Intracoronary imaging can be used during the entire process of percutaneous coronary intervention (PCI), from pre-PCI to post-PCI stages. Notably, approximately 15-20% of patients who underwent angiographically successful PCI showed significant stent underexpansion, malapposition, intra-stent thrombus formation, and edge dissection on intracoronary imaging studies, including optical coherence tomography (OCT). Meanwhile, the role of pre-interventional fractional flow reserve (FFR) measurement has been well established and recommended by recent guideline. However, although previous studies evaluated the efficacy and safety of FFR-guided decision-making followed by angiographic stent implantation, they did not evaluate functionally optimized revascularization. Actually, the vessels with low post-PCI FFR had substantial proportions of suboptimized stented (underexpansion and acute malapposition) and residual disease in non-stented segments. Furthermore, several large observational studies have suggested that suboptimal physiologic results after PCI is associated with an increased risk of clinical events. Previously, the DOCTORS trial found out that OCT-guided PCI was associated with higher post-PCI FFR than angiography-guided PCI (0.94±0.04 vs. 0.92±0.05, P=0.005). Therefore, OCT can be a useful tool for acquiring functional optimal results after stent implantation. This synergic effect between OCT and post-PCI FFR can be maximized when the investigators perform PCI for complex lesions. This study sought to evaluate compare post-interventional FFR value between OCT-guided and angiography-guided strategy for treatment of complex coronary lesion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Angina Pectoris
Keywords
Percutaneous Coronary Intervention, Intravascular Imaging, Optical Coherence Tomography, Fractional Flow Reserve, Complex Lesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OCT-guided PCI arm
Arm Type
Active Comparator
Arm Description
Use of OCT will be strongly recommended at any step of PCI (pre-PCI, during PCI and post-PCI), but OCT evaluation after stent implantation will be mandatory. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended.
Arm Title
Angiography-guided PCI arm
Arm Type
Active Comparator
Arm Description
The PCI procedure in this group will be performed as standard procedure. After deployment of stent, stent optimization will be done based on angiographic findings. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended.
Intervention Type
Procedure
Intervention Name(s)
OCT-guided PCI
Intervention Description
For patients randomly allocated to this arm, PCI for complex lesions will be performed using OCT. OCT Reference site: Most normal looking segment, No Lipidic plaque. Operator can decide 1 of 2 methods for stent sizing. By measuring vessel diameter at the distal reference sites (in case of ≥180° of the external elastic membrane [EEL] can be identified). In this case, stent diameter will be determined using mean external elastic membrane diameter at the distal reference, rounded down to the nearest 0.25mm (Ex> mean external elastic membrane reference diameter 3.35mm, 3.25mm stent diameter will be chosen). By measuring lumen diameter at the distal reference sites (in case of ≥180° of the external elastic membrane cannot be identified). In this case, stent diameter will be determined using mean lumen diameter at the distal reference, rounded up to the nearest 0.25mm (Ex> mean distal reference lumen diameter 2.55mm, 2.75mm stent diameter will be chosen).
Intervention Type
Procedure
Intervention Name(s)
Angiography-guided PCI
Intervention Description
For patients randomly allocated to this arm, PCI for complex lesions will be performed using angiography only. The optimization guided by angiography should meet the criteria of angiographic residual diameter stenosis less than 30% by visual estimation and the absence of flow limiting dissection (≥Type C dissection). When angiographic under-expansion of the stent is suspected, adjunctive balloon dilatation will be strongly recommended.
Intervention Type
Device
Intervention Name(s)
Drug-eluting stent
Intervention Description
All patient will be received percutaneous coronary intervention with second generation drug-eluting stent.
Primary Outcome Measure Information:
Title
Suboptimal post-PCI physiological results
Description
Proportion of patients with a final post-interventional fractional flow reserve <0.85
Time Frame
Immediate after the index procedure
Secondary Outcome Measure Information:
Title
Rate of target vessel failure (TVF)
Description
a composite of cardiac death, target-vessel myocardial infarction (MI), and target-vessel revascularization (TVR)
Time Frame
2-Year after the index procedure
Title
Rate of all-cause death
Description
death from any-cause
Time Frame
2-Year after the index procedure
Title
Rate of cardiac death
Description
death from cardiac-cause
Time Frame
2-Year after the index procedure
Title
Rate of target vessel MI without periprocedural MI
Description
Myocardial infarction without periprocedural myocardial infarction
Time Frame
2-Year after the index procedure
Title
Rate of target vessel MI with periprocedural MI
Description
Myocardial infarction with periprocedural myocardial infarction
Time Frame
2-Year after the index procedure
Title
Rate of target lesion revascularization (TLR)
Description
ischemia-driven or all
Time Frame
2-Year after the index procedure
Title
Rate of target vessel revascularization (TVR)
Description
ischemia-driven or all
Time Frame
2-Year after the index procedure
Title
Rate of any MI
Description
any myocardial infarction
Time Frame
2-Year after the index procedure
Title
Rate of any revascularization
Description
ischemia-driven or all
Time Frame
2-Year after the index procedure
Title
Rate of stent thrombosis
Description
definite, probable, or possible
Time Frame
2-Year after the index procedure
Title
FFR gain between pre- and post-interventional stages
Description
[Post-interventional fractional flow reserve value] - [Pre-interventional fractional flow reserve value]
Time Frame
Immediate after the index procedure
Title
Trans-stent FFR gradient
Description
FFR gradient across the stent (ΔFFRstent)
Time Frame
Immediate after the index procedure
Title
Post-interventional non-hyperemic pressure ratios
Description
Values of post-PCI non-hyperemic pressure ratios
Time Frame
Immediate after the index procedure
Other Pre-specified Outcome Measures:
Title
Incidence of contrast-induced nephropathy
Description
defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline after contrast agent exposure
Time Frame
48-72 hours after index procedure
Title
Total procedure time
Description
Total procedure time
Time Frame
Immediate after the index procedure
Title
Total amount of contrast dose
Description
Total amount of contrast dose
Time Frame
Immediate after the index procedure
Title
Total fluoroscopy time
Description
Total fluoroscopy time
Time Frame
Immediate after the index procedure
Title
Total amount of radiation dose
Description
Total amount of radiation dose
Time Frame
Immediate after the index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients >18 years old Patients with stable or unstable angina and complex coronary lesions* Patients who were indicated revascularization Diameter stenosis >90% by angiography Diameter stenosis with 50~90% with pre-interventional FFR ≤0.80 Patients who underwent implantation of 2nd generation drug-eluting stent Definitions of complex coronary lesions True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size Chronic total occlusion (≥3 months) as target lesion PCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation) Long coronary lesions (implanted stent ≥38 mm in length) Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session) Multiple stents needed (≥3 more stent per patient) In-stent restenosis lesion as target lesion Severely calcified lesion (encircling calcium in angiography) Left anterior descending (LAD), left circumflex artery (LCX), and right coronary artery (RCA) ostial lesion Exclusion Criteria: Target lesions not amenable for PCI by operators' decision Cardiogenic shock (Killip class IV) at presentation Less than TIMI 3 flow of target vessel after index procedure Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock) Renal insufficiency such that an additional contrast medium would be harmful for patient Recent ST-segment elevation myocardial infarction (STEMI) Inability to receive adenosine or nicorandil injection Pregnancy or breast feeding Non-cardiac co-morbid conditions are present with life expectancy <2 year or that may result in protocol non-compliance (per site investigator's medical judgment) Unwillingness or inability to comply with the procedures described in this protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Youngkeun Ahn, MD, PhD
Phone
+82-62-220-4764
Email
cecilyk@hanmail.net
First Name & Middle Initial & Last Name or Official Title & Degree
Seung Hun Lee, MD, PhD
Phone
+82-10-6413-7449
Email
lsh8602@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youngkeun Ahn, MD, PhD
Organizational Affiliation
Chonnam National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Keimyung University Dongsan Hospital
City
Daegu
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-Wook Nam, MD, PhD
Email
namcwcv@gmail.com
First Name & Middle Initial & Last Name & Degree
Chang-Wook Nam, MD, PhD
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youngkeun Ahn, MD, PhD
Phone
82-62-220-5778
Email
cecilyk@hanmail.net
First Name & Middle Initial & Last Name & Degree
Seung Hun Lee, MD, PhD
Phone
82-62-220-4246
Email
lsh8602@naver.com
First Name & Middle Initial & Last Name & Degree
Youngkeun Ahn, MD, PhD
First Name & Middle Initial & Last Name & Degree
Seung Hun Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Min Chul Kim, MD, PhD
First Name & Middle Initial & Last Name & Degree
Joon Ho Ahn, MD, PhD
First Name & Middle Initial & Last Name & Degree
Young Joon Hong, MD, PhD
Facility Name
Chung-Ang University Gwangmyeong Hospital
City
Gwangmyeong
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Yeob Lee, MD, PhD
Email
louisahj@gmail.com
First Name & Middle Initial & Last Name & Degree
Sang Yeob Lee, MD, PhD
Facility Name
Jeju National University Hospital
City
Jeju
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Song Yi Kim, MD, PhD
Email
ttoromom@jejunu.ac.kr
First Name & Middle Initial & Last Name & Degree
Song Yi Kim, MD, PhD
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD, PhD
Email
drone80@hanmail.net
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ki Hong Choi, MD, PhD
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bon-Kwon Koo, MD, PhD
Email
bkkoo@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Bon-Kwon Koo, MD, PhD
First Name & Middle Initial & Last Name & Degree
Doyeon Hwang, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
IPD Sharing Time Frame
1 year after study completion
IPD Sharing Access Criteria
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Learn more about this trial

PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX)

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