Intravascular Imaging-Guided Versus Angiography- Guided P... | NCT07297641

Studies
Intravascular Imaging-Guided Versus Angiography- Guided PCI in Patients With DES-ISR

NCT07297641

Sponsor

Nanjing First Hospital, Nanjing Medical University

Status

Recruiting

Last Update Posted

Dec 22, 2025Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

PCI
In-stent Restenosis
Intravascular Imaging Device

Interventions

percutaneous coronary intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Nov 1, 2026Estimated

Completion Date

Aug 1, 2027Estimated

First Submitted Date

Dec 9, 2025

First Submission Date that Met QC Criteria

Dec 9, 2025

First Posted Date

Dec 22, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2025

Last Update Posted Date

Dec 22, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ye-fei, chief physician, Nanjing First Hospital, Nanjing Medical UniversityPrincipal Investigator

Lead Sponsor

Nanjing First Hospital, Nanjing Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aimed to compare the clinical and angiographic outcomes of patients with DES-ISR who underwent repeat PCI with intravascular imaging or angiographic guidance.

Detailed Description

Through early revascularization, percutaneous coronary intervention (PCI) and following pharmacotherapy have improved clinical prognosis among patients with coronary artery disease. However, the presence of stent failure events remained posing long-term risk of adverse cardiac events. Although the utilization of drug-eluting stents (DES), the incidence of in-stent restenosis (ISR) continued to occur at an incidence rate of 1-2% annually. Also, the prognosis of ISR was worse than that in denovo lesions considering its complex mechanisms(stent under-expansion, neointimal hyperplasia or neo-atherosclerosis).Compared with coronary angiography, intravascular imaging(OCT/IVUS) provides detailed anatomical information regarding reference vessel dimensions and lesion characteristics, including severity of diameter stenosis, lesion length, and morphology. Identifying the mechanism of stent failure is paramount because the causative factors will influence the selection of treatment strategy, ultimately impacting the prognosis of the revascularization. However, clinical evidence for the exact benefit of intravascular imaging-guidance for ISR lesions is limited.

Therefore, this study aimed to compare the efficacy and safety of intravascular imaging -guided PCI in patients with ISR.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intravascular imaging -guidance		Individuals underwent intravascular imaging -guided PCI for lesions diagnosed with ISR	Procedure: percutaneous coronary intervention
Angiography-guidance		Individuals underwent angiography-guided PCI for lesions diagnosed with ISR	Procedure: percutaneous coronary intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
percutaneous coronary intervention	Procedure	Percutaneous Coronary Intervention for ISR	Angiography-guidance Intravascular imaging -guidance

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACE	Major adverse cardiovascular events following PCI	3-year

Secondary Outcomes

Measure	Description	Time Frame
Stent expansion	defined as the final minimal luminal area (MLA) within the treatment segment divided by the average reference vessel area	Intraprocedural
MSA	minimal stent area

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) Patients with DES-ISR lesions; (2) Life expectancy of at least 1 year; (3) DES-ISR lesions occurring for the first time in native coronary arteries and suitable for re-PCI based on angiographic findings.

Exclusion Criteria:

(1) Bare-metal stent in-stent restenosis (BMS-ISR). (2) Non-DES-ISR lesions. (3) Incomplete clinical and angiographic data. (4) Poor quality of IVUS or angiographic images. (5) Recurrent DES-ISR. (6) Optical coherence tomography (OCT) guidance.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

The first-time drug-eluting stent in-stent restenosis (DES-ISR) who underwent repeat percutaneous coronary intervention (re-PCI) under angiographic guidance or combined IVUS guidance.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Fei Ye, MD	Contact	18951670287 +86		doctor_ye@126.com
Yi-fei Wang, MD	Contact	18852577798 +86		happywangyf2018@163.com

Overall Officials

Name	Affiliation	Role
Fei Ye	Nanjing First Hospital, Nanjing Medical University, 210006 Nanjing, Jiangsu, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing First Hospital	Recruiting	Nanjing	Jiangsu	210006	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39620882	Result	Wang YF, Xu T, Meng PN, You W, Xu Y, Kong XH, Wu XQ, Wu ZM, Zhao MY, Jia HB, Wang F, Ye F. Optical coherence tomography versus angiography to guide percutaneous coronary intervention in patients with in-stent restenosis: an observational study. Coron Artery Dis. 2025 Mar 1;36(2):108-116. doi: 10.1097/MCA.0000000000001458. Epub 2024 Dec 3.

ID	Term
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative