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Mechanism-Based Assessment of In-Stent Restenosis Using a Hybrid IVUS/OCT System and Its Impact on Optimizing Periprocedural Reintervention Strategies

Mechanism-Based Assessment of In-Stent Restenosis Using a Hybrid IVUS/OCT System and Its Impact on Optimizing Periprocedural Reintervention Strategies

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600127034
Enrollment
Unknown
Registered
2026-06-23
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Coronary Artery Disease

Interventions

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years; 2. Previous implantation of metallic stents (BMS or DES) and planned for coronary angiography; 3. Coronary angiography indicates in-stent restenosis (ISR): > 50% stenosis at the stent segment and the 5 mm margins proximal and distal; 4. Intraoperative IVUS/OCT integrated imaging can be completed (at the stent segment and the marginal segments proximal and distal); 5. Able to understand the research content and sign the informed consent form, and agree to complete 12-month follow-up and laboratory re-examination.

Exclusion criteria

Exclusion criteria: 1. For critical cases that require urgent treatment and do not allow additional imaging time (such as difficulties in maintaining hemodynamic stability, etc.); 2. For materials related to imaging examinations (such as contrast agents / flushing solutions) that are clearly contraindicated and cannot be replaced; 3. If the target lesion guide wire / catheter cannot pass or it is predicted that integrated machine imaging cannot be safely completed; 4. Other situations that the researcher deems unsuitable for inclusion (such as poor compliance, inability to complete follow-up, etc.).

Design outcomes

Primary

MeasureTime frame
The ISR mechanism classification based on IVUS/OCT all-in-one machine and the composition spectrum of NA phenotypes (mechanical mechanism, NA stability phenotype, plaque burden, etc.);

Secondary

MeasureTime frame
Perioperative strategic decision-making changes based on intraluminal imaging mechanism information;The relationship between endovascular imaging mechanism phenotypes and clinical risk factors;

Countries

China

Contacts

Public ContactZhang Min

Beijing Anzhen Hospital, Capital Medical University

minjun1977@sina.com+86 135 2028 2850

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026