Evaluate the Clinical Efficacy and Safety of Non-Compliant PTCA Balloon Dilatation Catheter

NCT07855003 | Completed

• 1 other identifier: SINOMED-SCB-PTCA-202603
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief Summary

This multi-center, retrospective study included patients diagnosed with coronary artery stenosis treated with NC PTCA balloons between January 2026 and March 2026 at three real-world centers in central China.

Conditions

Coronary Artery Stenosis; Coronary Artery Disease; Coronary Balloon

Outcome Measures

Primary Outcomes (2)

• Device Success Rate

  The balloon successfully reached and crossed the target lesion, was successfully inflated, deflated, and withdrawn back into the guide catheter.

  immediate post-intervention

• Procedural Success Rate

  Device success, with no device-related adverse events occurring during the inflation process.

  immediate post-intervention

Secondary Outcomes (4)

• Major Adverse Cardiovascular Events (MACE) during hospitalization

  during hospitalization, 3-7 days post-procedure

• Target Lesion Failure (TLF) during hospitalization

  during hospitalization, 3-7 days post-procedure

• All-cause mortality during hospitalization

  during hospitalization, 3-7 days post-procedure

• Any myocardial infarction during hospitalization

  during hospitalization, 3-7 days post-procedure

Interventions

balloon angioplasty DEVICE

The balloon catheter expands a stenotic portion of the coronary artery or bypass graft during percutaneous transluminal coronary angioplasty (PTCA). The balloon catheter can be used for post-delivery expansion of balloon expandable stents.

Eligibility Criteria

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

Study Population

Patients with coronary heart disease (CHD) who were treated with at least one NC PTCA balloon dilatation catheter during PCI and had complete case information.

You may qualify if:

• Age ≥18 years.
• The native coronary artery or bypass graft has a stenotic lesion suitable for Percutaneous Coronary Intervention (PCI).
• The patient voluntarily underwent NC PTCA treatment (pre-dilation before stent implantation and/or post-dilation after stent implantation).

You may not qualify if:

• The Instructions for Use (IFU) clearly specify contraindications, and patient data with incomplete case information that affects the evaluation of the primary endpoint.

Sponsors & Collaborators

• TEDA International Cardiovascular Hospital: lead

Study Sites (3)

Lixin County People's Hospital

Bozhou, China

Location

Dangshan County Traditional Chinese Medicine Hospital

Suzhou, China

Location

TEDA International Cardiovascular Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Coronary Stenosis; Coronary Artery Disease

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Wenhua Lin

  TEDA International Cardiovascular Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: October 2, 2026
• Study Start: July 1, 2026
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

CN (3)