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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: RIPC

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.

• Study Type: Interventional
• Enrollment (Actual): 430
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Fuwai Central China Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; 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; 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
No Intervention: Control; 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?

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)

Collaborators and Investigators

• Sponsor: Henan Institute of Cardiovascular Epidemiology
• Investigators: Study Chair: Muwei Li, MD, Fuwai Central China Cardiovascular Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2021
• Primary Completion (Actual): February 20, 2022
• Study Completion (Actual): May 20, 2023

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: HenanICE202104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: After the results are published, researchers can obtain IPD from the responsible person on reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No