NCT04766749

Remote Ischemic Preconditioning on the Prognosis of Patients With Elective PCI Using Drug-coated Balloon

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 430 (actual)
• Sponsor: Henan Institute of Cardiovascular Epidemiology · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Drug-coated balloon is being used more and more widely for the advantage of intervention without implantation. But the balloon needs to be released long enough to be effective. Prolonged balloon dilation resulting in the cessation of blood flow in the distal vessels, especially large vessels, may result in severe ischemia in the patient. RIPC can enhance patients' tolerance to ischemic events, so we believe that RIPC application before the use of drug balloon for PCI can improve patients' ischemic symptoms, thus increasing the release time of drug balloon and improving the effect.

Detailed description

Some patients receiving PCI cannot tolerate the symptoms of myocardial ischemia caused by the release of the drug balloon for a long time and even lead to the occurrence of adverse events.RIPC was found to improve tolerance to myocardial ischemia in patients. At the same time, it can open collateral circulation and improve the tolerance of myocardial ischemia in patients.Therefore, this study designed a parallel control group. The experimental group was treated with RIPC before PCI, while the control group was not treated before PCI. The operator does not know whether the patient has undergone RIPC or not, and the operator decides the time of drug balloon release according to the symptoms of the patient during the operation.Angiography was performed at 6 months, and QCA was used to determine late lumen loss at 1 year.The 1-year incidence of target lesion failure events was assessed.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	RIPC	RIPC is delivered with a standard blood pressure cuff placed on the upper thigh. The cuffs are inflated to 200 mm Hg and keep inflated for 5 minutes,Then deflated to 0 mmHg and keep uninflated for 5 minutes, This cycle is repeated four times

Timeline

• Start date: 2021-02-24
• Primary completion: 2022-02-20
• Completion: 2023-05-20
• First posted: 2021-02-23
• Last updated: 2023-12-07

Locations

1 site across 1 country: China