Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth

NCT00349895 | Completed Phase 4 DMC

• 1 other identifier: HEALING IIb
• Study Type: interventional
• Target: 100
• Locations: 6 countries
• Sites: 15

Brief Summary

This is a multi-center, prospective, non-randomized study. Approximately 90 patients from up to 16 centers will be entered in the study. Patients will be followed clinically for up to 5 years post-procedure. All patients will have a repeat angiography at 6 months follow-up. The primary objective of this study is to evaluate the safety and effectiveness of the Genous Bio-engineered R stentTM in conjunction with optimal statin therapy (80mg of atorvastatin), in the treatment of elective patients with up to two de novo native coronary artery lesions. The Genous stent received CE mark for the intended indication in August 2005

Conditions

Coronary Artery Disease; Coronary Artery Stenosis

Keywords

Percutaneous Transluminal Coronary Angioplasty; Stent implantation

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this study is in-stent late loss by Quantitative Coronary Angiography (QCA).

  at 6 months

Secondary Outcomes (13)

• Angiographic success.

  during procedure

• Procedure success.

  during the index hospitalization

• Angiographic and/or clinical stent thrombosis.

  Up to 5 years

• In-stent late loss

  at 18 months.

• Binary restenosis rate

  at 6 and 18 months.

Interventions

Coronary stent implantation DEVICE

Percutaneous Coronary Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 85 years of age;
• Symptomatic ischemic heart disease (CCS class 1-4, Braunwald class IB, IC, and/or objective evidence of myocardial ischemia);
• Treatment of 1 or 2 de novo lesions;
• Target lesion(s) is(are) located in a native coronary artery, which can be covered by one single stent of maximum 33 mm; The coronary artery lesion should be ≤27 mm in length (a margin of 3mm proximal and 3mm distal is recommended) and should be entirely covered by one single Genous Bio-engineered R stentTM . If predilation of the lesion is visually deemed necessary it should be performed prior to measuring the length of the lesion.
• Reference vessel diameter ≥ 2.5 and ≤ 3.75 mm by visual estimate;
• Acceptable candidate for coronary artery bypass surgery (CABG);
• Target lesion stenosis is ≥50% and \<100% (minimum TIMI flow I at the time of the PCI procedure) (visual estimate);
• The patient is willing to comply with the specified follow-up evaluation;
• The patient has been informed of the nature of the study agrees to its provisions and has provided written informed consent, approved by the appropriate Ethics Committee (EC).

You may not qualify if:

• Women who are pregnant or women of childbearing potential who do not use adequate contraception;
• A Q-wave or non-Q-wave myocardial infarction within 72 hours preceding the index procedure, unless the CK and CK-MB enzymes or Troponin levels are less than twice the Upper Normal Limit;
• Impaired renal function (creatinine \> 3.0 mg/dl or 265 µmol/l);
• Any patient who has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3 or a WBC of \< 3,000 cells/mm3;
• Documented or suspected liver disease (including laboratory evidence of hepatitis);
• Recipient of heart transplant;
• Any patient who previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti-murine Antibodies (HAMA);
• Patient with a life expectancy less than the follow-up period (5 years);
• Known allergies to aspirin, clopidogrel bisulphate (Plavix®) and ticlopidine (Ticlid®), heparin, or stainless steel;
• Known side-effects (clinically demonstrated by biological tests, elevated CK and liver assessments) to statins and previous attempts to treat side-effects were unsuccessful;
• Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
• Patients currently undergoing chemotherapy or immunosuppressant therapy;
• Patients with known malignancy(ies).
• Unprotected left main coronary artery disease with ≥ 50% stenosis;
• Ostial target lesion;

Sponsors & Collaborators

• OrbusNeich: lead

Study Sites (15)

Medizinische Universitätsklinik

Graz, 8036, Austria

Location

OLV Ziekenhuis Aalst

Aalst, 9300, Belgium

Location

AZ Middelheim

Antwerp, 2020, Belgium

Location

University Hospital Antwerp

Edegem, 2650, Belgium

Location

Virga Jesse Ziekenhuis

Hasselt, 3500, Belgium

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Herzzentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Herz- und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, 32545, Germany

Location

Internistische Klinik Dr. Müller

Munich, 81379, Germany

Location

Academisch Medisch Centrum

Amsterdam, 1105 AZ, Netherlands

Location

Amphia Ziekenhuis

Breda, 4818 CK, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

John Radcliflfe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (1)

• den Dekker WK, Houtgraaf JH, Onuma Y, Benit E, de Winter RJ, Wijns W, Grisold M, Verheye S, Silber S, Teiger E, Rowland SM, Ligtenberg E, Hill J, Wiemer M, den Heijer P, Rensing BJ, Channon KM, Serruys PW, Duckers HJ. Final results of the HEALING IIB trial to evaluate a bio-engineered CD34 antibody coated stent (GenousStent) designed to promote vascular healing by capture of circulating endothelial progenitor cells in CAD patients. Atherosclerosis. 2011 Nov;219(1):245-52. doi: 10.1016/j.atherosclerosis.2011.06.032. Epub 2011 Jun 25.

  PMID: 21763653 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Patrick W Serruys, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 10, 2006
• Study Start: August 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2012
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

BE (4); FR (1); DE (3); AU (1); NL (4); GB (2)