CompletedNCT01151033EURONOVAUpdated Jan 20, 2011

A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System

A Phase 2/3 interventional study of Drug Eluting Stent implantation in Myocardial Ischemia, sponsored by KCRI. Completed at 3 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-20.

Sponsored by KCRI · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 50
Allocation: Non-randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Myocardial Ischemia

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Myocardial Ischemia 3,242

Keywords

ProNOVA XR Polymer Free Drug Eluting Coronary Stent System
DES
stent
coronary artery lesions
ProNOVA
stent implantation

In context

Myocardial Ischemia

3,242 studies on the registry are indexed under Myocardial Ischemia; 390 are open to participants now.

This study's enrollment of 50 is below the median of 120 across 1,901 interventional studies indexed under Myocardial Ischemia.

Browse Myocardial Ischemia studies →

Lead sponsor

KCRI is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

General Inclusion Criteria:

Patient must be at least 18 years of age.
Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ProNOVA XR DES and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site.
Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
Patient must agree to undergo all required follow-up examinations.
Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.

Angiographic Inclusion Criteria:

Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy)
Target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
Target lesion ≤ 28 mm in length by visual estimate

Exclusion Criteria:

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.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 50 participants (actual)

Study arms

Experimental
stent implantation
ProNOVA XR Polymer Free Drug Eluting Stent implantation - single arm
Device: Drug Eluting Stent implantation

Interventions

DeviceDrug Eluting Stent implantation
ProNOVA XR Drug Eluting Stent implantation

What researchers measure

Primary outcomes

In-stent late luminal loss
Time frame: at 6 months after stent implantation

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

Study locations

3 sites

Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Krakow, Poland
Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Sacz
Nowy Sącz, Poland
Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Targ
Nowy Targ, Poland

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2008, a primary completion of Sep 2010 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 18, 2010
First posted: Jun 25, 2010
Start: Nov 2008
Primary completionActual: Sep 2010
CompletionActual: Sep 2010
Last update: Jan 20, 2011

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01151033
Lead sponsor: KCRI
Collaborators: Vascular Concepts Limited
First posted: Jun 25, 2010
Start date: Nov 2008
Primary completion: Sep 2010
Completion: Sep 2010
Last update: Jan 20, 2011

Study contacts

Dariusz Dudek, MD, PhD

principal investigator · Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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