Trials / Completed
CompletedNCT06013007
Joint Inflation With Nominal-pressure and Stability Approach in DES Optimization
Joint Inflation With Nominal-pressure and Stability Approach in Coronary Drug-Eluting Stent Optimization and Outcomes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 161 (actual)
- Sponsor
- Zunyi Medical College · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
To achieve the stent optimization following "Keep It Simple and Safe" coronary intervention is recommended. A protocol of Joint Inflation with Nominal-pressure and Stability (JINS) approach in coronary drug-eluting stent (DES) implantation by intracoronary imaging (ICI) guidance could provide additional benefits in reducing unnecessary radiation exposure, and post-dilatation balloon angioplasty-related complications.
Detailed description
Variable types of stent inflation protocol to achieve evidence and consensus-based coronary drug-eluting stent (DES) optimization could improve clinical outcomes. The investigators aim to evaluate whether the JINS approach could be adopted in Chinese daily practice. The investigators will perform ICI (OCT or IVUS)-guided DES implantation in coronary de novo lesions by JINS protocol, described as inflating stent balloon with nominal-pressure (+1\~2atm) without decay for at least 30 seconds.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | ICI-guided JINS approach | OCT- or IVUS-guided JINS approach in DES implantation (DES types including Healing-Targeted SUPREME/Infinity Sirolimus-Eluting Stent, GuReater™ Sirolimus-Eluting Stent, XIENCE Alpine Everolimus-Eluting Stent, Promus PREMIER™ Everolimus-Eluting Stent, Resolute Integrity™ Zotarolimus-Eluting Stent, Firebird 2™ Sirolimus-Eluting Stent, Firekingfisher™ Sirolimus-Eluting Stent). |
Timeline
- Start date
- 2023-08-22
- Primary completion
- 2026-03-05
- Completion
- 2026-03-05
- First posted
- 2023-08-28
- Last updated
- 2026-03-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06013007. Inclusion in this directory is not an endorsement.