Numen Stent Assessment Using OCT Technique in a Single Center Study

NCT00774917 | Unknown Phase 2

• 1 other identifier: CSC-IBS/05-2007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective single centre Study designed to assess by OCT the effect of NUMEN cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or ACS (except STEMI). A total of 60 consecutive patients will be enrolled in the study. Patients with de novo native coronary artery lesions \>10mm and \<24mm in length and \>2.50mm to \<3.50mm in diameter by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent implantation. After stent deployment an OCT imaging will be performed within the treated segment. Patients will be followed at 30 days, 6 months and 12 months post-procedure, with all patients having repeat angiography and OCT at 6 months. It is anticipated that the total length of the study will be 18 months: 6 months to complete patient enrolment and 12 months for follow-up.

Conditions

Hyperplasia; Restenosis

Keywords

numen; hyperplasia

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the assessment of the development of neointimal hyperplasia by OCT in the stented segment at 6-month follow-up.

  6 months

Secondary Outcomes (1)

• Endothelialization of the stent internal wall by OCT at 6 months ; (MACE) at 30 days, 6 and 12 months Angiographic binary restenosis at 6m Target vessel failure at 6m. Device, lesion, procedure success. Thrombosis

  12 months

Study Arms (1)

Numen

EXPERIMENTAL

Device: Numen

Interventions

Numen DEVICE

Numen Co-Cr coronary stent implant

Numen

Eligibility Criteria

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

You may qualify if:

• Patients must meet all of the following criteria:
• The patient must be \> 18 years of age;
• Diagnosis of stable angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) or ACS (except STEMI).
• Treatment of de novo lesion in a major coronary artery in patients with single or two-vessel disease.
• Target vessel diameter at the lesion site is \>2.50mm and \<3.50mm in diameter (QCA);
• Target lesion is \>10mm and \<24mm in length (visual estimate);
• Target lesion stenosis is \>50% and \<100% (visual estimate);
• Acceptable candidate for coronary artery bypass surgery (CABG);
• Patient is willing to comply with the specified follow-up evaluation;
• Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee.

You may not qualify if:

• Patients will be excluded if any of the following conditions apply:
• multiple lesions in the same vessel;
• ACS with STEMI (within 48 hours)
• vessel size \< 2.50mm and \>3.50mm reference diameter;
• length of the lesion \> 24 mm;
• unprotected left main coronary disease with \>50% stenosis;
• have an ostial target lesion;
• have a target lesion in a venous graft;
• angiographic evidence of thrombus within target lesion;
• calcified lesion which cannot be successfully predilated;
• Documented left ventricular ejection fraction \>25%;
• Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
• Pretreatment with devices other than balloon angioplasty;
• Prior stent within 5mm of target lesion;
• Recipient of heart transplant;

Sponsors & Collaborators

• International Biomedical Systems S.p.A.: lead
• CSC Pharmaceuticals: collaborator

Study Sites (2)

University Hospital of Vienna

Vienna (Austria), Vienna, Austria

RECRUITING

SMZ-Ost Donauspital

Vienna, Austria

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Hyperplasia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helmut Dietmar Glogar, Prof.

  University Hospital of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helmut-Dietmar Glogar, Professor

CONTACT

01/40400-4614

Mariann Pavone Gyongyosi, Doz. Dr.

CONTACT

01/40400-4614

Study Design

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

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: October 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: March 1, 2010
• Last Updated: June 23, 2009

Record last verified: 2009-06

Locations

AU (2)