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

NCT01151033 | Completed Phase 2

• 1 other identifier: XR I
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Myocardial Ischemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• In-stent late luminal loss

  at 6 months after stent implantation

Secondary Outcomes (21)

• Clinically and non-clinically indicated target lesion revascularization

  at 30 days

• Clinically and non-clinically indicated target vessel revascularization

  at 30 days

• Incidence of total and cardiovascular death

  at 30 days

• Incidence of nonfatal myocardial infarction

  at 30 days

• Definite, probable, and possible stent thrombosis

  at 30 days

Study Arms (1)

stent implantation

EXPERIMENTAL

ProNOVA XR Polymer Free Drug Eluting Stent implantation - single arm

Device: Drug Eluting Stent implantation

Interventions

Drug Eluting Stent implantation DEVICE

ProNOVA XR Drug Eluting Stent implantation

stent implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• KCRI: lead
• Vascular Concepts Limited: collaborator

Study Sites (3)

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

Krakow, Poland

Location

Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Sacz

Nowy Sącz, Poland

Location

Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Targ

Nowy Targ, Poland

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Dariusz Dudek, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: June 25, 2010
• Study Start: November 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 20, 2011

Record last verified: 2011-01

Locations

PL (3)