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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: RIPC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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 | Other: RIPC<br>* 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<br>|
| No Intervention: Control<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TLF | TLF, a composite of cardiac death, target vessel-related myocardial infarction (MI; not clearly attributed to a nontarget vessel and excluding periprocedural MI), or clinically indicated target lesion revascularization (TLR) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss of target vessel（mm） | Late Lumen Loss of target vessel（mm） by Quantitative Coronary Angiography (QCA). | 6 months | 
| DCB expansion time | We hypothesis/speculated that the RIPC group had better ischemia tolerance, so the balloon dilation time was longer than the control group. But the total time for all patients is less than 120 seconds | less than 120 seconds (On the 1 day of PCI) |