Clinical trial NCT01151033: A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Myocardial Ischemia
Keywords: ProNOVA XR Polymer Free Drug Eluting Coronary Stent System
DES
stent
coronary artery lesions
ProNOVA
stent implantation
Lead sponsor: KCRI
Sponsor class: OTHER
Collaborators: name: Vascular Concepts Limited
First posted: 2010-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: In-stent late luminal loss
timeFrame: at 6 months after stent implantation
Secondary outcomes:
measure: Clinically and non-clinically indicated target lesion revascularization
timeFrame: at 30 days
measure: Clinically and non-clinically indicated target vessel revascularization
timeFrame: at 30 days
measure: Incidence of total and cardiovascular death
timeFrame: at 30 days
measure: Incidence of nonfatal myocardial infarction
timeFrame: at 30 days
measure: Definite, probable, and possible stent thrombosis
timeFrame: at 30 days
measure: Clinically and non-clinically indicated target lesion revascularization
timeFrame: at 6 months
measure: Clinically and non-clinically indicated target vessel revascularization
timeFrame: at 6 months
measure: Incidence of total and cardiovascular death
timeFrame: at 6 months
measure: Incidence of nonfatal myocardial infarction
timeFrame: at 6 months
measure: Definite, probable, and possible stent thrombosis
timeFrame: at 6 months
measure: Clinically and non-clinically indicated target lesion revascularization
timeFrame: at 12 months
measure: Clinically and non-clinically indicated target vessel revascularization
timeFrame: at 12 months
measure: Incidence of total and cardiovascular death
timeFrame: at 12 months
measure: Incidence of nonfatal myocardial infarction
timeFrame: at 12 months
measure: Definite, probable, and possible stent thrombosis
timeFrame: at 12 months
measure: In-stent and in-segment percent diameter stenosis (% DS)
timeFrame: at 6 months after stent implantation
measure: In-stent and in-segment binary restenosis rate as assessed by QCA
timeFrame: at 6 months after stent implantation
measure: In-stent and in-segment minimal luminal diameter (MLD)as assessed by QCA
timeFrame: at 6 months after stent implantation
measure: In-stent and in-segment late luminal loss as assessed by QCA
timeFrame: at 6 months after stent implantation
measure: Neointimal hyperplasia as assessed by intravascular ultrasound (IVUS)
timeFrame: at 6 months after stent implantation
measure: Rate of incomplete stent apposition as assessed by intravascular ultrasound (IVUS)
timeFrame: at 6 months after stent implantation
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
city: Nowy Sacz
country: Poland
facility: Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Sacz
city: Nowy Targ
country: Poland
facility: Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Targ
Study officials:
affiliation: Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
name: Dariusz Dudek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: