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

NCT07297641 | Recruiting

• 1 other identifier: KY20241223-KS-02
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

PCI; In-stent Restenosis; Intravascular Imaging Device

Keywords

in-stent restenosis; Intravascular imaging device; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• MACE

  Major adverse cardiovascular events following PCI

  3-year

Secondary Outcomes (2)

• Stent expansion

  Intraprocedural

• MSA

  Intraprocedural

Study Arms (2)

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

percutaneous coronary intervention PROCEDURE

Percutaneous Coronary Intervention for ISR

Angiography-guidance; Intravascular imaging -guidance

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39620882 RESULT

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Fei Ye

  Nanjing First Hospital, Nanjing Medical University, 210006 Nanjing, Jiangsu, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Ye, MD

CONTACT

18951670287 +86; doctor_ye@126.com

Yi-fei Wang, MD

CONTACT

18852577798 +86; happywangyf2018@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)