Optimizing stent implantation for heart conditions using a new inflation method
Joint Inflation With Nominal-pressure and Stability Approach in Coronary Drug-Eluting Stent Optimization and Outcomes
This study is testing a new way to implant heart stents using a special inflation method to see if it helps patients with heart conditions feel better and have fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Zunyi Medical College Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Zunyi, Guizhou) |
| Trial ID | NCT06013007 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel approach called Joint Inflation with Nominal-pressure and Stability (JINS) for optimizing drug-eluting stent (DES) implantation in patients with acute coronary syndrome. The JINS method involves using intracoronary imaging guidance to inflate the stent balloon at a nominal pressure for a specified duration, aiming to enhance clinical outcomes while minimizing complications and radiation exposure. The research will assess the feasibility and effectiveness of this approach in routine clinical practice in China.
Who should consider this trial
Good fit: Ideal candidates include patients with acute coronary syndrome who are scheduled for OCT- or IVUS-guided DES implantation in de novo lesions.
Not a fit: Patients with left main lesions, high thrombus burden, or significant comorbidities such as active bleeding or severe renal failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes and reduced complications for patients undergoing stent implantation.
How similar studies have performed: While this specific approach is novel, similar studies utilizing intracoronary imaging for stent optimization have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with acute coronary syndrome (UA/NSTEMI/STEMI) plan to undergo OCT- or IVUS-guided DES implantation in de novo lesion. * Patients provide written informed consent prior to enrollment. Exclusion Criteria: * Left main, ostial right coronary artery lesion. * High thrombus burden at the index primary percutaneous coronary intervention. * Active bleeding or bleeding diathesis, thrombocytopenia (platelet \<100,000/mL), or hemoglobin \<10 g/dL * Hepatic dysfunction (serum liver enzyme\>3 times the normal limit) * Renal failure (eGFR \<15 ml/min/1.73m2 or requiring dialysis) * Life expectancy \< 1 year
Where this trial is running
Zunyi, Guizhou
- Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Recruiting)
Study contacts
- Principal investigator: Cai De Jin, MD — Zunyi Medical College
- Study coordinator: Cai De Jin, MD
- Email: jincaide@zmu.edu.cn
- Phone: 86+178-0250-2582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.