Myocardial IschemiaPhase 2/3EURONOVANCT01151033
A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System
A Phase 2/3 study testing Drug Eluting Stent implantation in people with Myocardial Ischemia, run by KCRI at 3 sites in Poland.
Trial summary
The objective of this study is the assessment of the performance, safety and efficacy of the ProNOVA XR Polymer Free Drug Eluting Stent System in the treatment of patients with de novo native coronary artery lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- Drug Eluting Stent implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesPoland
- Study dates
- Nov 2008to Sep 2010
- Phase
- Phase 2/3
- 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
None listed.
Who cannot join
- Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
- Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, cobalt, chromium, nickel, or contrast sensitivity that cannot be adequately pre-medicated
- Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days
- Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Krakow
Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Sacz
Nowy Sącz
Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Targ
Nowy Targ
About this study
Official title: A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions
The objective of this study is the assessment of the performance, safety and efficacy of the ProNOVA XR Polymer Free Drug Eluting Stent System in the treatment of patients with de novo native coronary artery lesions.
Read the detailed description
This study is a prospective, single arm, multicenter registry of approximately 50 patients undergoing PCI with the ProNOVA Drug Eluting Coronary Stent System according to its Instructions for Use.
The purpose of this registry is the evaluation of the performance, safety and efficacy of ProNOVA XR DES in real-world patients. Following initial stent implantation, all patients will have clinical follow up at 30 days, at 6 and 12 months. Additionally all patients will have a angiographic F/U at 6 months to assess the late luminal loss by QCA measurements and the neointimal volume including stent apposition by intravascular ultrasound.
- Conditions
- Myocardial Ischemia
- Being tested
- Drug Eluting Stent implantation
- Keywords
- ProNOVA XR Polymer Free Drug Eluting Coronary Stent System, DES, stent, coronary artery lesions, ProNOVA, stent implantation
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Eluting Stent implantationDevice
ProNOVA XR Drug Eluting Stent implantation
| Study group | Role | What they receive |
|---|---|---|
| stent implantation | Experimental | ProNOVA XR Polymer Free Drug Eluting Stent implantation - single arm Receives: Device: Drug Eluting Stent implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent late luminal loss
Measured: at 6 months after stent implantation
Secondary outcomes (21)
Clinically and non-clinically indicated target lesion revascularization
Measured: at 30 days
Clinically and non-clinically indicated target vessel revascularization
Measured: at 30 days
Incidence of total and cardiovascular death
Measured: at 30 days
Incidence of nonfatal myocardial infarction
Measured: at 30 days
Definite, probable, and possible stent thrombosis
Measured: at 30 days
Clinically and non-clinically indicated target lesion revascularization
Measured: at 6 months
Clinically and non-clinically indicated target vessel revascularization
Measured: at 6 months
Incidence of total and cardiovascular death
Measured: at 6 months
Incidence of nonfatal myocardial infarction
Measured: at 6 months
Definite, probable, and possible stent thrombosis
Measured: at 6 months
Clinically and non-clinically indicated target lesion revascularization
Measured: at 12 months
Clinically and non-clinically indicated target vessel revascularization
Measured: at 12 months
Incidence of total and cardiovascular death
Measured: at 12 months
Incidence of nonfatal myocardial infarction
Measured: at 12 months
Definite, probable, and possible stent thrombosis
Measured: at 12 months
In-stent and in-segment percent diameter stenosis (% DS)
Measured: at 6 months after stent implantation
In-stent and in-segment binary restenosis rate as assessed by QCA
Measured: at 6 months after stent implantation
In-stent and in-segment minimal luminal diameter (MLD)as assessed by QCA
Measured: at 6 months after stent implantation
In-stent and in-segment late luminal loss as assessed by QCA
Measured: at 6 months after stent implantation
Neointimal hyperplasia as assessed by intravascular ultrasound (IVUS)
Measured: at 6 months after stent implantation
Rate of incomplete stent apposition as assessed by intravascular ultrasound (IVUS)
Measured: at 6 months after stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startNov 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial IschemiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCRI
- Sponsor type
- University, hospital or other
- Collaborators
- Vascular Concepts Limited
- Investigators
- Dariusz Dudek, MD, PhD, Principal investigator, Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151033
- Sponsor's protocol ID
- XR I
- Acronym
- EURONOVA
- Status last verified
- Jan 2011
- First submitted
- 18 Jun 2010
- Last updated
- 20 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT01151033
- Acronym / sponsor ID
- EURONOVA / XR I
- Conditions
- Myocardial Ischemia
- Keywords
- ProNOVA XR Polymer Free Drug Eluting Coronary Stent System, DES, stent, coronary artery lesions, ProNOVA, stent implantation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KCRIUniversity, hospital or other
- Collaborators
- Vascular Concepts Limited
- Study start
- Nov 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 25 Jun 2010 (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 objective of this study is the assessment of the performance, safety and efficacy of the ProNOVA XR Polymer Free Drug Eluting Stent System in the treatment of patients with de novo native coronary artery lesions.
Detailed description
This study is a prospective, single arm, multicenter registry of approximately 50 patients undergoing PCI with the ProNOVA Drug Eluting Coronary Stent System according to its Instructions for Use.
The purpose of this registry is the evaluation of the performance, safety and efficacy of ProNOVA XR DES in real-world patients. Following initial stent implantation, all patients will have clinical follow up at 30 days, at 6 and 12 months. Additionally all patients will have a angiographic F/U at 6 months to assess the late luminal loss by QCA measurements and the neointimal volume including stent apposition by intravascular ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stent implantation | Experimental | Device: Drug Eluting Stent implantationProNOVA XR Polymer Free Drug Eluting Stent implantation - single arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
- Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, cobalt, chromium, nickel, or contrast sensitivity that cannot be adequately pre-medicated
- Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days
- Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
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 |
|---|---|---|
| Drug Eluting Stent implantationProNOVA XR Drug Eluting Stent implantation | Device | stent implantation |
Primary outcome
In-stent late luminal loss
Time frame: at 6 months after stent implantation
21 secondary outcomes
Clinically and non-clinically indicated target lesion revascularization
Time frame: at 30 days
Clinically and non-clinically indicated target vessel revascularization
Time frame: at 30 days
Incidence of total and cardiovascular death
Time frame: at 30 days
Incidence of nonfatal myocardial infarction
Time frame: at 30 days
Definite, probable, and possible stent thrombosis
Time frame: at 30 days
Clinically and non-clinically indicated target lesion revascularization
Time frame: at 6 months
Clinically and non-clinically indicated target vessel revascularization
Time frame: at 6 months
Incidence of total and cardiovascular death
Time frame: at 6 months
Incidence of nonfatal myocardial infarction
Time frame: at 6 months
Definite, probable, and possible stent thrombosis
Time frame: at 6 months
Clinically and non-clinically indicated target lesion revascularization
Time frame: at 12 months
Clinically and non-clinically indicated target vessel revascularization
Time frame: at 12 months
Incidence of total and cardiovascular death
Time frame: at 12 months
Incidence of nonfatal myocardial infarction
Time frame: at 12 months
Definite, probable, and possible stent thrombosis
Time frame: at 12 months
In-stent and in-segment percent diameter stenosis (% DS)
Time frame: at 6 months after stent implantation
In-stent and in-segment binary restenosis rate as assessed by QCA
Time frame: at 6 months after stent implantation
In-stent and in-segment minimal luminal diameter (MLD)as assessed by QCA
Time frame: at 6 months after stent implantation
In-stent and in-segment late luminal loss as assessed by QCA
Time frame: at 6 months after stent implantation
Neointimal hyperplasia as assessed by intravascular ultrasound (IVUS)
Time frame: at 6 months after stent implantation
Rate of incomplete stent apposition as assessed by intravascular ultrasound (IVUS)
Time frame: at 6 months after stent implantation
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 20 Jan 2011.
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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.
Dariusz Dudek, MD, PhD principal investigator
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Drug Eluting Stent implantation in people with Myocardial Ischemia, run by KCRI at 3 sites in Poland.
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 0 inclusion and 4 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 20 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
In-stent late luminal loss (time frame: at 6 months after stent implantation). 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 20 Jan 2011.