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

Coronary Artery Disease Clinical Trial

— RIPC-DCB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04766749
• Other study ID #: HenanICE202104
• Status: Completed
• Phase: N/A
• Start date: February 24, 2021
• Est. completion date: May 20, 2023

Study information

• Verified date: December 2023
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: May 20, 2023
• Est. primary completion date: February 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
China	Fuwai central China cardiovascular Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Late lumen loss of target vessel(mm)	Late Lumen Loss of target vessel(mm) by Quantitative Coronary Angiography (QCA).	6 months
Secondary	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)