Acute Myocardial InfarctionPOST-STEMINCT02121223
POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary With OCT Assessment
A study testing post-dilatation with a Quantum Maverick balloon and manual thrombus aspiration + Promus Element stent implant in people with Acute Myocardial Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
To evaluate the effective and safety of post-dilatation in patients with acute ST segment elevated myocardial infarction undergoing primary percutaneous intervention after thrombus aspiration assessed by optical coherence tomography to examine stent Incomplete apposition and strut coverage in patients treated with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- post-dilatation with a Quantum Maverick balloon and manual thrombus aspiration + Promus Element stent implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Jul 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Clinical Inclusion Criteria:
- Age ≥18 years
- STEMI >20 mins and <12 hours in duration
- ST-segment elevation of ≥1 mm in ≥2 contiguous leads; or Presumably new left bundle branch block; or True posterior MI with ST depression of ≥1 mm in ≥2 contiguous anterior leads
- Written, informed consent
Angiographic Inclusion Criteria
- The presence of least 1 acute infarct artery target vessel* in which:
- ALL significant lesions are eligible for stenting with study stents, and
- ALL such lesions have a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm
- All culprit lesion TIMI Flow ≤ 0 or 1 Grade prior to guide wire crossing
- Expected ability to deliver the stent(s) to all culprit lesions (absence of excessive proximal tortuosity or severe calcification)
- Expected ability to fully expand the stent(s) at all culprit lesions (absence of marked calcification)
Clinical Exclusion Criteria:
- Contraindication to any of the study medications
- Patients with cardiogenic shock
- History of bleeding diathesis or known coagulopathy , or will refuse blood transfusions
- History of intracerebral mass, aneurysm, AVM, or hemorrhagic stroke; stroke or TIA within 6 months or any permanent neurologic deficit; GI or GU bleed within 2 months, or major surgery within 6 weeks; recent or known platelet count <100,000 cells/mm3 or hgb <10 g/dL
- Planned elective surgical procedure that would necessitate interruption of thienopyridines during the first 6 months post enrollment
Angiographic Exclusion Criteria
- Bifurcation lesion definitely requiring implantation of stents in both the main vessel + side branch
- Infarct related artery is an unprotected left main
- >38 mm of study stent length anticipated
- Infarction due to stent thrombosis, or infarct lesion at the site of a previously implanted stent
- High likelihood of CABG within 30 days anticipated
- The culprit lesion will be judged unsuitable for OCT procedure, because of conditions such as left main trunk disease or shock vital
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jun Jiang, MD, 8657187784705, drjayj@hotmail.com
About this study
Official title: A Prospective, Multi-center,Randomized Controled Trial of POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary PCI After Thrombus Aspiration and DES Implantation With OCT Assessment
To evaluate the effective and safety of post-dilatation in patients with acute ST segment elevated myocardial infarction undergoing primary percutaneous intervention after thrombus aspiration assessed by optical coherence tomography to examine stent Incomplete apposition and strut coverage in patients treated with drug-eluting stents .
- Conditions
- Acute Myocardial Infarction
- Being tested
- post-dilatation with a Quantum Maverick balloon, manual thrombus aspiration + Promus Element stent implant
- Keywords
- acute ST segment elevated myocardial infarction, primary percutaneous intervention, Stent Incomplete Apposition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-dilatation with a Quantum Maverick balloonDevice
post-dilatation with a Quantum Maverick balloon at high pressure (>=16atm) for at least 15 seconds.
manual thrombus aspiration + Promus Element stent implantDevice
manual thrombus aspiration followed by Promus Element stent implantation at normal pressure
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients in control group will receive current standard therapy for STEMI: manual thrombus aspiration + Promus Element stent implantation ( with a pressure less than 12 atm), but not post-dilatation Receives: Device: manual thrombus aspiration + Promus Element stent implant |
| Post-dilatation | Experimental | Patients in this group will receive high pressure post-dilatation with a Quantum Maverick balloon after manual thrombus aspiration + Promus Element stent implantation Receives: Device: post-dilatation with a Quantum Maverick balloon; Device: manual thrombus aspiration + Promus Element stent implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month
Measured: 7 months after primary PCI
Secondary outcomes (8)
Final TIMI flow grade 3
Measured: Immediately after primary PCI procedure (up to 2 min)
Final TIMI blush Grade 3
Measured: Immediately after primary PCI procedure (up to 2 min)
Rate of ST resolution 70% at 30 day
Measured: 30 days after primary PCI
Rate of strut coverage in OCT at 7 month
Measured: 7 months after primary PCI
MACE at 7 month and 12 month
Measured: 7 months and 12 months after primary PCI
TLR ,TLF at 7 month and 12 month
Measured: 7 months and 12months after primary PCI
Stent thrombus rate at 30 day,7 month and 12 month
Measured: 30 days, 7 months and 12 months after primary PCI
In-stent and in-segment late loss
Measured: 7 months after primary PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Shanghai East Hospital, Ningbo No. 1 Hospital
- Responsible party
- Principal investigator, Jian'an Wang,MD,PhD, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Jianan Wang, MD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121223
- Sponsor's protocol ID
- SAHZJU CT002
- Acronym
- POST-STEMI
- Status last verified
- Apr 2014
- First submitted
- 3 Apr 2014
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jiang J, Tian NL, Cui HB, Li CL, Liu XB, Dong L, Sun Y, Chen XM, Chen SL, Xu B, Wang JA. Post-dilatation improves stent apposition in patients with ST-segment elevation myocardial infarction receiving primary percutaneous intervention: A multicenter, randomized controlled trial using optical coherence tomography. World J Emerg Med. 2020;11(2):87-92. doi: 10.5847/wjem.j.1920-8642.2020.02.004.
PubMed 32076473
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center,Randomized Controled Trial of POST-dilatation to Improve Outcomes in Acute STEMI Patients Undergoing Primary PCI After Thrombus Aspiration and DES Implantation With OCT Assessment
- ClinicalTrials.gov ID
- NCT02121223
- Acronym / sponsor ID
- POST-STEMI / SAHZJU CT002
- Conditions
- Acute Myocardial Infarction
- Keywords
- acute ST segment elevated myocardial infarction, primary percutaneous intervention, Stent Incomplete Apposition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Shanghai East Hospital, Ningbo No. 1 Hospital
- Study start
- Apr 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 23 Apr 2014 (estimated)
- 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 effective and safety of post-dilatation in patients with acute ST segment elevated myocardial infarction undergoing primary percutaneous intervention after thrombus aspiration assessed by optical coherence tomography to examine stent Incomplete apposition and strut coverage in patients treated with drug-eluting stents .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: manual thrombus aspiration + Promus Element stent implantPatients in control group will receive current standard therapy for STEMI: manual thrombus aspiration + Promus Element stent implantation ( with a pressure less than 12 atm), but not post-dilatation |
| Post-dilatation | Experimental | Device: post-dilatation with a Quantum Maverick balloon, Device: manual thrombus aspiration + Promus Element stent implantPatients in this group will receive high pressure post-dilatation with a Quantum Maverick balloon after manual thrombus aspiration + Promus Element stent implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| post-dilatation with a Quantum Maverick balloonpost-dilatation with a Quantum Maverick balloon at high pressure (>=16atm) for at least 15 seconds. | Device | Post-dilatation |
| manual thrombus aspiration + Promus Element stent implantmanual thrombus aspiration followed by Promus Element stent implantation at normal pressure | Device | Control, Post-dilatation |
Primary outcome
Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month
Time frame: 7 months after primary PCI
8 secondary outcomes
Final TIMI flow grade 3
Time frame: Immediately after primary PCI procedure (up to 2 min)
Final TIMI blush Grade 3
Time frame: Immediately after primary PCI procedure (up to 2 min)
Rate of ST resolution 70% at 30 day
Time frame: 30 days after primary PCI
Rate of strut coverage in OCT at 7 month
Time frame: 7 months after primary PCI
MACE at 7 month and 12 month
Time frame: 7 months and 12 months after primary PCI
TLR ,TLF at 7 month and 12 month
Time frame: 7 months and 12months after primary PCI
Stent thrombus rate at 30 day,7 month and 12 month
Time frame: 30 days, 7 months and 12 months after primary PCI
In-stent and in-segment late loss
Time frame: 7 months after primary PCI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
- Derived from this study: PubMed 32076473Jiang J, Tian NL, Cui HB, Li CL, Liu XB, Dong L, Sun Y, Chen XM, Chen SL, Xu B, Wang JA. Post-dilatation improves stent apposition in patients with ST-segment elevation myocardial infarction receiving primary percutaneous intervention: A multicenter, randomized controlled trial using optical coherence tomography. World J Emerg Med. 2020;11(2):87-92. doi: 10.5847/wjem.j.1920-8642.2020.02.004.
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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.
Jianan Wang, MD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing post-dilatation with a Quantum Maverick balloon and manual thrombus aspiration + Promus Element stent implant in people with Acute Myocardial Infarction, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Jun Jiang, MD (8657187784705, drjayj@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Incomplete Stent Apposition (ISA) in OCT at 7 month (time frame: 7 months after primary PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121223, which also lists 1 linked publication.
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 23 Apr 2014.