Comparison of performance with and without conventional high pressure post-dilation on vascular wall injury and its curative effect: a multicenter, noninferior, randomized, controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900023650

Enrollment

Unknown

Registered

2019-06-05

Start date

2019-07-01

Completion date

Unknown

Last updated

2019-06-11

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

Conditions

coronary artery disease

Interventions

Experimental Group:without conventional HPPD

Control group:conventional HPPD

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 80 years old; 2. Patients with stable or unstable angina, or NSTEMI; 3. De novo lesions; 4. Lesions suitable for PCI (the SYNTAX score <32 if lesions located at LM); 5. Patients willing to receive all protocol-required evaluations; 6. Patients completely understand the trial requirements and treatment procedures and provide written informed consent before any trial-specific tests or procedures are performed.

Exclusion criteria

Exclusion criteria: 1. Patients with STEMI (within 24-hour from the onset of chest pain to admission); 2. Lesions not suitable for PCI (the SYNTAX score =32 if lesions located at LM bifurcation, or any PCI-related contraindications including patient conditions and/or lesion characteristics); 3. Lesion with severe calcification; 4. Bifurcation lesions requiring two stent technique or side branch balloon dilatation; 5. Patients intolerable to long-term dual anti-platelet therapy; 6. Patients with obvious hematopoietic disorders (e.g., platelet count700×10^9/L, leukocyte count5 times of normal upper limit), heart failure (NYHA class =III class); 9. Patients with any other serious medical illness that life expectancy is less than 12 months; 10. Woman with pregnancy or planning to pregnancy; 11. Patients with known allergy to the study stent system (sirolimus, everolimus, zotarolimus) or to protocol-required concomitant medications; 12. Patients with a planned or planning procedure that may cause non-compliance with the present protocol or confound data interpretation.

Design outcomes

Primary

Measure	Time frame
Rate of target lesion failure;	—

Countries

China

Contacts

Public ContactChen Lianglong

Department of Cardiology, Fujian Medical University Union Hospital

lianglongchenxh@126.com+86 591-83342282

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026