Polymer Free Stent in Acute Coronary Syndrome

NCT03878966 | Unknown

• 1 other identifier: polymer free stent
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the short term out comes of the polymer free stents in patients presented with non ST elevation acute coronary syndrome (which include ST depression myocardial infarction and unstable angina ) after percutaneous coronary intervention .

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (2)

• • Major adverse cardiac events (MACE)

  * Recurrent angina pectoris, post-infarction angina, new or recurrent myocardial infarction. * Target lesion revascularization (TLR). * Target vessel revascularization (TVR). * Left ventricular dysfunction. * Cardiac arrhythmias. * Cardiac death.

  During six months after the intervention .

• Mortality rate

  Mortality rate in patients underwent the intervention

  Within six months of the intervention

Secondary Outcomes (1)

• • Instent restenosis

  six months after the intervention

Study Arms (1)

Invasive Strategy group

EXPERIMENTAL

* Our study will be conducted on at least thirty patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS)-which include ST depression myocardial infarction and unstable angina- who will be subjected to the early invasive strategy . Polymer-free drug eluting stents will be used for these patients instead of the usually used polymer-permanent drug eluting stents .

Device: Inserting polymer free drug eluting stent in the coronary arteries

Interventions

Inserting polymer free drug eluting stent in the coronary arteries DEVICE

• Early invasive strategy with percutaneous coronary intervention will be done for the patients presenting with NST ACS who meet the inclusion criteria using Polymer-free drug eluting stents instead of the polymer-permanent drug eluting stents .

Invasive Strategy group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients from 18 to 85 years of both genders presented with NSTE-ACS with TIMI score ( ≥ 3), who will be subjected to early invasive strategy, whose coronary angiography shows de novo coronary artery disease (CAD) with a stenotic lesion ≥ 70 % requiring use of 2 stents or less.

You may not qualify if:

• Patients with NSTEACS who will be subjected to conservative strategy.
• Patients whose coronary angiography shows CAD with significant lesions not candidate for PCI like target lesion location in the left main stem or multi vessel disease .
• In-stent restenosis .
• Stenosis in bypass graft .
• Raised renal chemistry (serum creatinine \> 2 mg/dl) .
• Known allergy to the contrast media or other medications used during and after percutaneous coronary intervention .
• Contraindication to antiplatelet (Asprin, Clopidogrel) or heparin therapy e.g. significant external or internal bleeding and active peptic ulcer .
• Severly impaired LV systolic function (LVEF \< 35%).
• Malignancies or other co-morbid conditions (for example, severe liver, renal, and pancreatic disease) with life expectancy\<6 months or that may result in protocol non-compliance .
• Pregnancy .
• Previous enrolment in this trial

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of internal medicine ,critical care unit

Model Details: • Our study will be conducted on at least thirty patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS)-which include ST depression myocardial infarction and unstable angina- who will be subjected to the early invasive strategy . Polymer-free drug eluting stents will be used for these patients instead of the usually used polymer-permanent drug eluting stents .

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 18, 2019
• Study Start: August 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 5, 2019

Record last verified: 2019-03