Acute Coronary SyndromeNCT03878966
Polymer Free Stent in Acute Coronary Syndrome
A study testing Inserting polymer free drug eluting stent in the coronary arteries in people with Acute Coronary Syndrome, run by Assiut University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Inserting polymer free drug eluting stent in the coronary arteries
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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 .
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- 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
About this study
Official title: Polymer Free Drug Eluting Stent in Non ST Elevation Acute Coronary Syndrome
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 .
Read the detailed description
One of the treatment options for CAD is a percutaneous coronary intervention through balloon angioplasty or stent insertion . Although the restenosis rate can be reduced by using bare metal stents , the in-stent restenosis (ISR) rate is still high at around 20%-30% .
increased rates of stent thrombosis were reported with first-generation DESs.(5) The high rate of late and very late stent thrombosis is caused by a long duration of drug elution, which can delay endothelial healing and prolong metallic structure exposure to blood vessel .
Conventionally, DES (drug eluting stents ) are coated with permanent polymers that facilitate drug release and remain long after drug elution is complete. These permanent polymers can cause delayed healing, impaired stent strut endothelialization , and a hypersensitivity reaction, which can culminatein ST (stent thrombosis ).
Research has led to the design of the newer DES (drug eluing stents) that have biodegradable polymers, novel coatings, or are completely polymer free. The polymer-free technology has the potential advantage to reduce the inflammatory and prothrombotic risks related to the utilization of polymers .
- Our study will be conducted on at least thirty patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS)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 .
- Patients with NST-ACS who will meet the inclusion and exclusion criteria will be subjected to the following during the admission in the ICU :
- History of the patient concerning :
- Analysis of presenting complaint . Past history of previous similar complaints or the coarse of his illness if he is known to have IHD(ischemic heart disease ) before . Risk factors ( Diabetus mellitus , hypertension , smoking ,....) .Any other co-morbidities and therapeutic history .
- Examination will be done with special concern payied for:
- Blood pressure, heart rate, respiratory rate, Jugular Venous Pressure (JVP), cardiac examination and chest auscultation .
- Investigations in the form of:
- Serial 12 lead ECG .
- Laboratory investigations : (Complete Blood Count (CBC) , Prothrombine time and concentration ,Kidney function ,HCV-Ab , HBs-Ag , HIV Ab , Creatine kinase (CK and CK-MB ) and Troponin at admission and 6 hours later ) .
- Imaging:
- Echocardiographic evaluation with certain emphasis on the following parameters (Wall motion abnormalities ,systolic function , diastolic function and cardiac dimensions).
- TIMI (Thrombolysis in Myocardial Infarction ) risk score will be calculated to every patient .
- Each of the following criteria constitutes one point for TIMI scoring :
- Age ≥65 years
- Three or more risk factors for coronary artery disease (CAD) (family history of CAD, hypertension, hypercholesterolemia, diabetes mellitus, tobacco use)
- Known CAD (stenosis >50%)
- Aspirin use in the past 7 days
- Severe angina (≥2 episodes in 24 hours)
- ST deviation ≥0.5 mm
- Elevated cardiac marker level
- Syntax score will be caiculated during PCI .
- Early invasive strategy with percutaneous coronary intervention will be done for these patients using Polymer-free drug eluting stents instead of the polymer-permanent drug eluting stents .
- The patients will be followed for 6 months after the intervention .
- The patients included in the study will be followed up and re-evaluated at one month and six months after the intervention ( by telephon calls and office visits )
- Re-evaluation will include asking about and analysing symptoms of IHD after the PCI , compliance to the medications .
- Examination: Vital signs , JVP , chest and heart examination .
- 12-lead ECG and cardiac enzymes if needed .
- Follow up Echocardiography will be done at six months .
- Patients will be subjected to follow up diagnostic coronary angiography six months of PCI (whenever possible).
- Six months views after the index procedure coronary angiography will be evaluated by quantitative coronary angiography (QCA) with edge detection method used for evaluation of coronary lesion in index and follow up procedures. Minimal luminal diameter (MLD), Reference vessel diameter (RVD), Percent diameter stenosis %DS), Acute Gain, Late loss and Late loss index will be estimated.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Inserting polymer free drug eluting stent in the coronary arteries
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inserting polymer free drug eluting stent in the coronary arteriesDevice
- 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 .
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Device: Inserting polymer free drug eluting stent in the coronary arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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.
Measured: During six months after the intervention .
Mortality rate
Mortality rate in patients underwent the intervention
Measured: Within six months of the intervention
Secondary outcomes (1)
• Instent restenosis
defined as > 50% instent diameter restenosis on the follow up coronary angiogram.
Measured: six months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- • 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 .
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samir Ali Mahfouz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878966
- Sponsor's protocol ID
- polymer free stent
- Status last verified
- Mar 2019
- First submitted
- 15 Mar 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymer Free Drug Eluting Stent in Non ST Elevation Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03878966
- Acronym / sponsor ID
- polymer free stent
- Conditions
- Acute Coronary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
One of the treatment options for CAD is a percutaneous coronary intervention through balloon angioplasty or stent insertion . Although the restenosis rate can be reduced by using bare metal stents , the in-stent restenosis (ISR) rate is still high at around 20%-30% .
increased rates of stent thrombosis were reported with first-generation DESs.(5) The high rate of late and very late stent thrombosis is caused by a long duration of drug elution, which can delay endothelial healing and prolong metallic structure exposure to blood vessel .
Conventionally, DES (drug eluting stents ) are coated with permanent polymers that facilitate drug release and remain long after drug elution is complete. These permanent polymers can cause delayed healing, impaired stent strut endothelialization , and a hypersensitivity reaction, which can culminatein ST (stent thrombosis ).
Research has led to the design of the newer DES (drug eluing stents) that have biodegradable polymers, novel coatings, or are completely polymer free. The polymer-free technology has the potential advantage to reduce the inflammatory and prothrombotic risks related to the utilization of polymers .
- Our study will be conducted on at least thirty patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS)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 .
- Patients with NST-ACS who will meet the inclusion and exclusion criteria will be subjected to the following during the admission in the ICU :
- History of the patient concerning :
- Analysis of presenting complaint . Past history of previous similar complaints or the coarse of his illness if he is known to have IHD(ischemic heart disease ) before . Risk factors ( Diabetus mellitus , hypertension , smoking ,....) .Any other co-morbidities and therapeutic history .
- Examination will be done with special concern payied for:
- Blood pressure, heart rate, respiratory rate, Jugular Venous Pressure (JVP), cardiac examination and chest auscultation .
- Investigations in the form of:
- Serial 12 lead ECG .
- Laboratory investigations : (Complete Blood Count (CBC) , Prothrombine time and concentration ,Kidney function ,HCV-Ab , HBs-Ag , HIV Ab , Creatine kinase (CK and CK-MB ) and Troponin at admission and 6 hours later ) .
- Imaging:
- Echocardiographic evaluation with certain emphasis on the following parameters (Wall motion abnormalities ,systolic function , diastolic function and cardiac dimensions).
- TIMI (Thrombolysis in Myocardial Infarction ) risk score will be calculated to every patient .
- Each of the following criteria constitutes one point for TIMI scoring :
- Age ≥65 years
- Three or more risk factors for coronary artery disease (CAD) (family history of CAD, hypertension, hypercholesterolemia, diabetes mellitus, tobacco use)
- Known CAD (stenosis >50%)
- Aspirin use in the past 7 days
- Severe angina (≥2 episodes in 24 hours)
- ST deviation ≥0.5 mm
- Elevated cardiac marker level
- Syntax score will be caiculated during PCI .
- Early invasive strategy with percutaneous coronary intervention will be done for these patients using Polymer-free drug eluting stents instead of the polymer-permanent drug eluting stents .
- The patients will be followed for 6 months after the intervention .
- The patients included in the study will be followed up and re-evaluated at one month and six months after the intervention ( by telephon calls and office visits )
- Re-evaluation will include asking about and analysing symptoms of IHD after the PCI , compliance to the medications .
- Examination: Vital signs , JVP , chest and heart examination .
- 12-lead ECG and cardiac enzymes if needed .
- Follow up Echocardiography will be done at six months .
- Patients will be subjected to follow up diagnostic coronary angiography six months of PCI (whenever possible).
- Six months views after the index procedure coronary angiography will be evaluated by quantitative coronary angiography (QCA) with edge detection method used for evaluation of coronary lesion in index and follow up procedures. Minimal luminal diameter (MLD), Reference vessel diameter (RVD), Percent diameter stenosis %DS), Acute Gain, Late loss and Late loss index will be estimated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- • 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 .
| Arm | Type | Receives |
|---|---|---|
| Invasive Strategy group | Experimental | Device: Inserting polymer free drug eluting stent in the coronary arteries* 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 . |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- • Patients with NSTEACS who will be subjected to conservative strategy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inserting polymer free drug eluting stent in the coronary arteries• 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 . | Device | Invasive Strategy group |
Primary outcome
• Major adverse cardiac events (MACE)
Time frame: During six months after the intervention .
* 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.
Mortality rate
Time frame: Within six months of the intervention
Mortality rate in patients underwent the intervention
1 secondary outcome
• Instent restenosis
Time frame: six months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Inserting polymer free drug eluting stent in the coronary arteries in people with Acute Coronary Syndrome, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Major adverse cardiac events (MACE) (time frame: During six months after the intervention .). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.