First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions (BIOFLOW-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01214148
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : August 12, 2013
Information provided by (Responsible Party):
Biotronik AG

Brief Summary:

A prospective, single-treatment, multi centre clinical trial enrolling 30 patients in 2 centres in Romania, with a clinical and angiographic follow-up at 4 and 9 months to determine the primary endpoint of late lumen loss and secondary endpoints. A subgroup of 15 patients will also undergo post implantation, 4 and 9 months IVUS examinations. Additional clinical follow-ups take place at 1 month and yearly up to three (3) years.

The objective of this trial is to assess the safety and clinical performance of the ORSIRO drug eluting stent in patients with single de-novo coronary artery lesions.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: ORSIRO - Drug Eluting Coronary Stent Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-centre, Single Treatment Clinical Trial With Follow-up Investigations at 1, 4, 9, 12, 24 and 36 Months
Study Start Date : July 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : July 2013

Arm Intervention/treatment
ORSIRO Device: ORSIRO - Drug Eluting Coronary Stent
The coronary stent is delivered to the intended implantation location by means of the fast-exchange delivery system and then expanded to its final diameter by dilating the balloon. It remains in the vessel as a permanent implant.

Primary Outcome Measures :
  1. In-stent Late Lumen Loss [ Time Frame: 9 months post procedure ]

Secondary Outcome Measures :
  1. In-stent and in-segment binary restenosis rate [ Time Frame: 4 and 9 months post procedure. ]
  2. In-stent and in-segment (proximal and distal) minimum lumen diameter [ Time Frame: 4 and 9 months post-procedure ]
  3. In-segment late lumen loss [ Time Frame: 4 and 9 months post procedure ]
  4. In-stent late lumen loss [ Time Frame: 4 months post procedure. ]
  5. Target Lesion Revascularization [ Time Frame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure ]
  6. Clinically driven target lesion revascularization [ Time Frame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure ]
  7. Target Vessel Revascularization [ Time Frame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure ]
  8. - Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization [ Time Frame: 1, 4 and 9 month post-procedure, and yearly up to 3 years ]
  9. - Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels [ Time Frame: 3 years post procedure ]
  10. Stent thrombosis [ Time Frame: 1, 4 and 9 months and 1, 2 and 3 years post-procedure ]
  11. Neointimal hyperplasia volume (subgroup) [ Time Frame: 4 and 9 months post-procedure measured by Intravascular Ultrasound (IVUS) ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is ≥18 years old;
  2. Clinical evidence of ischemic heart disease and / or a positive functional study. Documented stable angina pectoris (Canadian cardiovascular society classification (CCS) 1, 2, 3 or 4 ), or documented silent ischemia;
  3. Single de novo lesion with ≥50% and <90% stenosis in 1 coronary artery;

Exclusion Criteria:

  1. Documented left ventricular ejection fraction (LVEF) ≤30%;
  2. Unstable angina pectoris(Braunwald Class A I-III)
  3. Three-vessel coronary artery disease
  4. Evidence of myocardial infarction within 72 hours prior to the index procedure;
  5. Known allergies to the following: Acetylsalicylic acid (ASA) (Aspirin®), Clopidogrel bisulfate (Plavix®.) or Ticlopidine (Ticlid®.), Heparin, contrast agent (that cannot be adequately premedicated), cobalt-chromium (CoCr), Poly-L-Lactidic Acid (PLLA), silicon carbide (aSiC:H)
  6. A platelet count <100.000 cells/mm3 or >700.000 cells/mm3 or a WBC <3.000 cells/mm3;
  7. Acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or >150µmol/L);
  8. Total occlusion (TIMI 0 or 1);
  9. Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment;
  10. Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
  11. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
  12. Target lesion is located in or supplied by an arterial or venous bypass graft;
  13. Ostial target lesion (within 5.0mm of vessel origin);
  14. Target lesion involves a side branch >2.0mm in diameter;
  15. Unprotected Left main coronary artery disease (stenosis >50%);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01214148

Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu" - Spitalul Clinic Fundeni
Bucharest, Romania
Spitalul Clinic de Urgenţă Bucureşti
Bucharest, Romania
Sponsors and Collaborators
Biotronik AG
Principal Investigator: Martial Hamon, MD Centre Hospitalier Universitaire Caen

Responsible Party: Biotronik AG Identifier: NCT01214148     History of Changes
Other Study ID Numbers: C0904
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases