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To evaluate the safety and efficacy of portable non-gravity infusion device for intravenous infusion in patients with coronary heart disease undergoing selective PCI, a randomized, open, positive parallel controlled, multicenter clinical trial

To evaluate the safety and efficacy of portable non-gravity infusion device for intravenous infusion in patients with coronary heart disease undergoing selective PCI, a randomized, open, positive parallel controlled, multicenter clinical trial - Portable non-gravity infusion device

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083697
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-04-30
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Patients with coronary heart disease undergoing elective PCI

Interventions

Portable non-gravity infusion device:Portable non-gravity infusion
Disposable precision filter infusion set:Disposable precision filtration infusion

Sponsors

The Second affiliated Tangdu Hospital of Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (1) Age and gender are not limited; (2) The diagnosis of coronary heart disease was in accordance with the relevant criteria of the "Guidelines for the Diagnosis and Treatment of stable coronary heart Disease", with chest tightness and chest pain, and aggravation after activity, confirmed by coronary angiography; 3 patients underwent percutaneous coronary intervention (PCI); Iv infusion (infusion of isotonic crystalloid solution) was prescribed; 5 had venous access; 6 Voluntarily participated in the trial and signed the "informed consent" voluntarily.

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1 Allergic to device materials and/or drugs to be infused; 2 patients with symptoms of phlebitis; 3. Plan to infuse fat-soluble liquid such as photosensitive, high viscosity, blood products and fat emulsion; 4 pregnant or lactating women; 5 patients with left main disease or severe multivessel disease; 6 patients underwent emergency PCI; 7 acute myocardial infarction; 8 Complicated with unstable angina pectoris, cardiac function class ?, cardiogenic shock, uncontrolled hypertension (resting systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg); 9 with arrhythmia (malignant ventricular arrhythmia, second or third degree atrioventricular block, supraventricular tachycardia, atrial fibrillation); 10 patients with renal insufficiency and stroke; 11 patients with intraoperative complications (acute heart failure, pericardial tamponade, acute coronary occlusion, coronary perforation, cardiogenic shock); Having any emergency medical condition requiring first aid; 13 participated in other clinical trials within 1 month before enrollment and/or participated in clinical trials that have not yet been completed; 14 mental inability or inability to understand the requirements for trial participation; 15 Other conditions considered by the investigator to be inappropriate for enrollment, such as coexisting medical conditions that limit participation in the trial, predicted poor adherence, and so on.

Design outcomes

Primary

MeasureTime frame
Rate of pass;

Secondary

MeasureTime frame
Backflow resistance;no significant height difference in infusion function;

Countries

China

Contacts

Public ContactLi Yan

The Second affiliated Tangdu Hospital of Air Force Medical University

307712565@qq.com+86 29717761

Outcome results

None listed

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