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

Henan Institute of Cardiovascular Epidemiology

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Other: RIPC

Study type: Interventional

Funder types: Other

Identifiers

NCT04766749

HenanICE202104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 430 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diameter stenosis>=50% by visual estimation intend to undergo drug-coated balloon implantation
• Target vessel diameter> 2.5mm

Exclusion criteria

• Chronic Total Obstructive lesion
• Diagnose patients with acute myocardial infarction <24 hours
• Can't tolerate or not suitable for RIPC
• Severe hepatic and renal insufficiency
• Expected survival <1 year
• Severe calcification needing rotational atherectomy
• Intolerable to dual antiplatelet therapy

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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430 participants in 2 patient groups

Experimental

Experimental group

Description:

40 minutes before PCI by the nurse to the patient RIPC operation (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), and then do regular PCI operation

Treatment:

Other: RIPC

Control

No Intervention group

Description:

A standard cuff is placed on the patient's thigh by the nurse 40 minutes before PCI but it is not inflated. PCI is performed 40 minutes later