Coronary Heart DiseasePhase 4PEPCADNSTEMINCT01489449
Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction
A Phase 4 study testing Stent and SeQuent(R) Please coated balloon in people with Coronary Heart Disease and NSTEMI, run by University Hospital, Saarland at 1 site in Germany.
Trial summary
The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, NSTEMI
- What is being tested?
- Stent and SeQuent(R) Please coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2012to 23 Jun 2022
- Phase
- Phase 4
- 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
Who may be able to join
- NSTEMI with
- Ischemic symptoms (angina pectoris) > 30 minutes
- Last symptoms within 72 hours before randomization
- Positive cardiac troponin T, I, or hs-Troponin above 99th percentile
- age > 18 years
- Identifiable culprit lesion without angiographic evidence of large thrombus with intended early PCI (treatment of up to two lesions allowed)
Who cannot join
- Cardiogenic shock
- ST-elevation myocardial infarction
- No identifiable culprit lesion, Indication for acute bypass surgery
- Comorbidity with limited life expectancy < 9-12 months
- Contraindication for treatment with heparin, ASA and thienopyridines
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
Homburg/Saar, Saarland, 66421
About this study
The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI.
Read the detailed description
The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI. Primary efficacy endpoint will be MACE (cardiac mortality, reinfarction, and target lesion revascularization) after 9 months.
- Conditions
- Coronary Heart Disease, NSTEMI
- Being tested
- Stent, SeQuent(R) Please coated balloon
- Keywords
- drug coated balloon, NSTEMI
- Medical subject headings
- Coronary Disease, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentDevice
bare metal stent implantation, any bare metal stent is allowed from different companies
SeQuent(R) Please coated balloonCombination product
Also called SeQuent(R) Please
Angioplasty with Drug coated balloon (DCB)
| Study group | Role | What they receive |
|---|---|---|
| Stent | Placebo comparator | Stent Implantation (DES or BMS), no further treatment Receives: Device: Stent |
| DCB | Active comparator | "DEBonly" strategy: treatment with drug coated balloon, additional spot-stenting in case of severe dissection Receives: Combination Product: SeQuent(R) Please coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization
Measured: 9 months
Secondary outcomes (6)
Stent thrombosis (ARC
Measured: 9 months, 3 years, 5 years
Mortality (cardiac and non-cardiac)
Measured: 9 months, 3 years, 5 years
Reinfarction
Measured: 9 months, 3 years, 5 years
target lesion revascularization
Measured: 9 months, 3 years, 5 years
target vessel revascularization
Measured: 9 months, 3 years, 5 years
any revascularization
Measured: 9 months, 3 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startDec 2012
- Primary completion23 Jun 2018
- Study completion23 Jun 2022
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 Coronary Heart DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Scheller, MD, Principal investigator, Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489449
- Sponsor's protocol ID
- PEPCAD NSTEMI
- Acronym
- PEPCADNSTEMI
- Status last verified
- May 2023
- First submitted
- 27 Nov 2011
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Scheller B, Ohlow MA, Ewen S, Kische S, Rudolph TK, Clever YP, Wagner A, Richter S, El-Garhy M, Bohm M, Degenhardt R, Mahfoud F, Lauer B. Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial. EuroIntervention. 2020 Apr 17;15(17):1527-1533. doi: 10.4244/EIJ-D-19-00723.
PubMed 31659986
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bare Metal Stent Versus Drug Coated Balloon With Provisional Stenting in Non-ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01489449
- Acronym / sponsor ID
- PEPCADNSTEMI / PEPCAD NSTEMI
- Conditions
- Coronary Heart Disease, NSTEMI
- Keywords
- drug coated balloon, NSTEMI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- 23 Jun 2018 (actual)
- Study completion
- 23 Jun 2022 (actual)
- First posted
- 9 Dec 2011 (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.
The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI.
Detailed description
The aim of the present trial is to assess the efficacy of the standalone use of SeQuent(R) Please coated balloon compared to a bare metal stent (BMS) in patients with NSTEMI. Primary efficacy endpoint will be MACE (cardiac mortality, reinfarction, and target lesion revascularization) after 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent | Placebo comparator | Device: StentStent Implantation (DES or BMS), no further treatment |
| DCB | Active comparator | Combination Product: SeQuent(R) Please coated balloon"DEBonly" strategy: treatment with drug coated balloon, additional spot-stenting in case of severe dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- NSTEMI with
- Ischemic symptoms (angina pectoris) > 30 minutes
- Last symptoms within 72 hours before randomization
- Positive cardiac troponin T, I, or hs-Troponin above 99th percentile
- age > 18 years
Key exclusion criteria (5 listed)
- Cardiogenic shock
- ST-elevation myocardial infarction
- No identifiable culprit lesion, Indication for acute bypass surgery
- Comorbidity with limited life expectancy < 9-12 months
- Contraindication for treatment with heparin, ASA and thienopyridines
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 |
|---|---|---|
| Stentbare metal stent implantation, any bare metal stent is allowed from different companies | Device | Stent |
| SeQuent(R) Please coated balloonAlso: SeQuent(R) PleaseAngioplasty with Drug coated balloon (DCB) | Combination product | DCB |
Primary outcome
MACE
Time frame: 9 months
MACE means the occurence of cardiac death, reinfarction, or target lesion revascularization
6 secondary outcomes
Stent thrombosis (ARC
Time frame: 9 months, 3 years, 5 years
Mortality (cardiac and non-cardiac)
Time frame: 9 months, 3 years, 5 years
Reinfarction
Time frame: 9 months, 3 years, 5 years
target lesion revascularization
Time frame: 9 months, 3 years, 5 years
target vessel revascularization
Time frame: 9 months, 3 years, 5 years
any revascularization
Time frame: 9 months, 3 years, 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 31659986Scheller B, Ohlow MA, Ewen S, Kische S, Rudolph TK, Clever YP, Wagner A, Richter S, El-Garhy M, Bohm M, Degenhardt R, Mahfoud F, Lauer B. Bare metal or drug-eluting stent versus drug-coated balloon in non-ST-elevation myocardial infarction: the randomised PEPCAD NSTEMI trial. EuroIntervention. 2020 Apr 17;15(17):1527-1533. doi: 10.4244/EIJ-D-19-00723.
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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.
Bruno Scheller, MD principal investigator
Klinik fuer Innere Medizin III, Universitaetsklinikum des Saarlandes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stent and SeQuent(R) Please coated balloon in people with Coronary Heart Disease and NSTEMI, run by University Hospital, Saarland at 1 site in Germany.
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 6 May 2023. 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 Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MACE (time frame: 9 months). 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 NCT01489449, 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 6 May 2023.