In-stent RestenosisPREVAILNCT03260517
The PREVAIL Study
A study testing Medtronic Coronary Drug-Coated Balloon Catheter in people with In-stent Restenosis and Ischemic Heart Disease, run by Medtronic Vascular at 10 sites in 3 countries.
Trial summary
To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- In-stent Restenosis, Ischemic Heart Disease, Coronary Artery Disease
- What is being tested?
- Medtronic Coronary Drug-Coated Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 2 Oct 2017to 1 Aug 2019
- 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
- Subject with documented stable or unstable angina, and/or clinical evidence of ischemia
- Subject is an acceptable candidate for treatment with a Coronary Drug- Coated Balloon in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki.
Who cannot join
- Acute Myocardial Infarction within the previous 72 hours
- Planned treatment involves a bifurcation
- Three vessel disease
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Netherlands5 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam, 1091 AC
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
Haga Ziekenhuis locatie Leyweg
The Hague, 2545 AA
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Isala Klinieken
Zwolle, 8025 AB
Belgium3 sites
ZNA Middelheim
Antwerp, 2020
Ziekenhuis Oost-Limburg
Genk, 3600
CHU Liege
Liège, 4000
Italy2 sites
IRCCS Policlinico San Donato
Milan, 20097
Ospedale San Raffaele
Milan, 20132
About this study
Official title: A Clinical PeRformance EVAluatIon of a New Medtronic Coronary Drug-Coated BaLloon Catheter for the Treatment of De Novo Lesions, In-Stent Restenosis and Small Vessel Disease in Coronary Arteries: The PREVAIL Study
To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.
Read the detailed description
This study is a prospective, pre-market, multi-center, single arm study evaluating up to 50 subjects with symptoms of ischemic heart disease attributable to stenotic lesions of the coronary arteries that are amenable to treatment with the Medtronic Coronary Drug-Coated Balloon Catheter.
Patients with de novo lesions, In-Stent Restenosis or small vessel disease who qualify for percutaneous coronary interventions treatable with the device with a diameter between 2.0 mm to 4.0 mm and a length ≤25 mm will be screened and are intended to participate in this study.
Each subject is expected to be followed in the study for 12 months. Procedural/acute outcomes and clinical outcomes will be assessed at procedure, 30 days, 6 and 12 months.
- Being tested
- Medtronic Coronary Drug-Coated Balloon Catheter
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Coronary Drug-Coated Balloon CatheterDevice
Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm (Mdt Drug-Coated Balloon) | Experimental | Medtronic Coronary Drug-Coated Balloon Catheter used for dilatation of the target lesion. Receives: Device: Medtronic Coronary Drug-Coated Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent (in balloon) Late Lumen Loss (LLL) as measured by Quantitative coronary angiography (QCA) at six months
The average 6 months in-stent (in-balloon) LLL will be compared to a maximum acceptance rate. If in-stent (in-balloon) LLL is less than the maximum acceptance rate, then the trial will be considered to have met the primary endpoint.
Measured: At 6 months follow up
Secondary outcomes (8)
All deaths including cardiac death.procedure
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
Measured: 30 days, 6 months and 1 year after procedure
Target Vessel Myocardial Infarction (TVMI)
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
Measured: 30 days, 6 months and 1 year after procedure
Major adverse cardiac event (MACE) defined as composite of death, Myocardial infarction (MI), emergent Coronary Artery Bypass Graft (CABG) or repeat Target lesion revascularization (TLR) (clinically driven) by percutaneous or surgical methods
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures
Measured: 30 days, 6 months and 1 year after procedure
Target vessel failure (TVF) defined as cardiac death, TVMI, or clinically-driven Target vessel revascularization (TVR) by percutaneous or surgical methods.
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedures
Measured: 30 days, 6 months and 1 year after procedure
5. Target lesion failure (TLF) defined by a composite of cardiac death, TVMI, or clinically-driven TLR by percutaneous or surgical methods.
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
Measured: 30 days, 6 months and 1 year after procedure
All revascularizations (TLR, TVR and non-TVR).
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
Measured: 30 days, 6 months and 1 year after procedure
Stent Thrombosis rate as defined as definite, probable, possible, and overall stent thrombosis (according to Academic Research Consortium definition).
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
Measured: 30 days, 6 months and 1 year after procedure
Acute success (device, lesion and procedure success).
Clinical endpoints to be assessed at 30 days, 6 months and 1 year after procedure
Measured: 30 days, 6 months and 1 year after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start2 Oct 2017
- Primary completion29 Jan 2019
- Study completion1 Aug 2019
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 In-stent RestenosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260517
- Sponsor's protocol ID
- MDT17027DCB001
- Acronym
- PREVAIL
- Status last verified
- Sep 2019
- First submitted
- 10 Aug 2017
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grosso A, Neves de Faria RI, Bojke L, Donohue C, Fraser CI, Harron KL, Oddie SJ, Gilbert R. Cost-effectiveness of strategies preventing late-onset infection in preterm infants. Arch Dis Child. 2020 May;105(5):452-457. doi: 10.1136/archdischild-2019-317640. Epub 2019 Dec 13.
PubMed 31836635
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical PeRformance EVAluatIon of a New Medtronic Coronary Drug-Coated BaLloon Catheter for the Treatment of De Novo Lesions, In-Stent Restenosis and Small Vessel Disease in Coronary Arteries: The PREVAIL Study
- ClinicalTrials.gov ID
- NCT03260517
- Acronym / sponsor ID
- PREVAIL / MDT17027DCB001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 29 Jan 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 24 Aug 2017 (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 clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.
Detailed description
This study is a prospective, pre-market, multi-center, single arm study evaluating up to 50 subjects with symptoms of ischemic heart disease attributable to stenotic lesions of the coronary arteries that are amenable to treatment with the Medtronic Coronary Drug-Coated Balloon Catheter.
Patients with de novo lesions, In-Stent Restenosis or small vessel disease who qualify for percutaneous coronary interventions treatable with the device with a diameter between 2.0 mm to 4.0 mm and a length ≤25 mm will be screened and are intended to participate in this study.
Each subject is expected to be followed in the study for 12 months. Procedural/acute outcomes and clinical outcomes will be assessed at procedure, 30 days, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm (Mdt Drug-Coated Balloon) | Experimental | Device: Medtronic Coronary Drug-Coated Balloon CatheterMedtronic Coronary Drug-Coated Balloon Catheter used for dilatation of the target lesion. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject with documented stable or unstable angina, and/or clinical evidence of ischemia
- Subject is an acceptable candidate for treatment with a Coronary Drug- Coated Balloon in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki.
Key exclusion criteria (3 listed)
- Acute Myocardial Infarction within the previous 72 hours
- Planned treatment involves a bifurcation
- Three vessel disease
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 |
|---|---|---|
| Medtronic Coronary Drug-Coated Balloon CatheterMedtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty | Device | Treatment arm (Mdt Drug-Coated Balloon) |
Primary outcome
In-stent (in balloon) Late Lumen Loss (LLL) as measured by Quantitative coronary angiography (QCA) at six months
Time frame: At 6 months follow up
The average 6 months in-stent (in-balloon) LLL will be compared to a maximum acceptance rate. If in-stent (in-balloon) LLL is less than the maximum acceptance rate, then the trial will be considered to have met the primary endpoint.
8 secondary outcomes
All deaths including cardiac death.procedure
Time frame: 30 days, 6 months and 1 year after procedure
Target Vessel Myocardial Infarction (TVMI)
Time frame: 30 days, 6 months and 1 year after procedure
Major adverse cardiac event (MACE) defined as composite of death, Myocardial infarction (MI), emergent Coronary Artery Bypass Graft (CABG) or repeat Target lesion revascularization (TLR) (clinically driven) by percutaneous or surgical methods
Time frame: 30 days, 6 months and 1 year after procedure
Target vessel failure (TVF) defined as cardiac death, TVMI, or clinically-driven Target vessel revascularization (TVR) by percutaneous or surgical methods.
Time frame: 30 days, 6 months and 1 year after procedure
5. Target lesion failure (TLF) defined by a composite of cardiac death, TVMI, or clinically-driven TLR by percutaneous or surgical methods.
Time frame: 30 days, 6 months and 1 year after procedure
All revascularizations (TLR, TVR and non-TVR).
Time frame: 30 days, 6 months and 1 year after procedure
Stent Thrombosis rate as defined as definite, probable, possible, and overall stent thrombosis (according to Academic Research Consortium definition).
Time frame: 30 days, 6 months and 1 year after procedure
Acute success (device, lesion and procedure success).
Time frame: 30 days, 6 months and 1 year after procedure
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 30 Sep 2019.
- Derived from this study: PubMed 31836635Grosso A, Neves de Faria RI, Bojke L, Donohue C, Fraser CI, Harron KL, Oddie SJ, Gilbert R. Cost-effectiveness of strategies preventing late-onset infection in preterm infants. Arch Dis Child. 2020 May;105(5):452-457. doi: 10.1136/archdischild-2019-317640. Epub 2019 Dec 13.
- Individual participant dataSharing planned: Undecided
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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.
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Coronary Drug-Coated Balloon Catheter in people with In-stent Restenosis and Ischemic Heart Disease, run by Medtronic Vascular at 10 sites in 3 countries.
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 2 inclusion and 3 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 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands, Belgium, Italy. 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?
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?
In-stent (in balloon) Late Lumen Loss (LLL) as measured by Quantitative coronary angiography (QCA) at six months (time frame: At 6 months follow up). 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 NCT03260517, 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 30 Sep 2019.