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

September 30, 2010
October 4, 2010
August 12, 2013
July 2009
April 2010   (Final data collection date for primary outcome measure)
In-stent Late Lumen Loss [ Time Frame: 9 months post procedure ]
Same as current
Complete list of historical versions of study NCT01214148 on Archive Site
  • In-stent and in-segment binary restenosis rate [ Time Frame: 4 and 9 months post procedure. ]
  • In-stent and in-segment (proximal and distal) minimum lumen diameter [ Time Frame: 4 and 9 months post-procedure ]
  • In-segment late lumen loss [ Time Frame: 4 and 9 months post procedure ]
  • In-stent late lumen loss [ Time Frame: 4 months post procedure. ]
  • Target Lesion Revascularization [ Time Frame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure ]
  • Clinically driven target lesion revascularization [ Time Frame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure ]
  • Target Vessel Revascularization [ Time Frame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure ]
  • - 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 ]
  • - Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels [ Time Frame: 3 years post procedure ]
  • Stent thrombosis [ Time Frame: 1, 4 and 9 months and 1, 2 and 3 years post-procedure ]
  • Neointimal hyperplasia volume (subgroup) [ Time Frame: 4 and 9 months post-procedure measured by Intravascular Ultrasound (IVUS) ]
Same as current
Not Provided
Not Provided
First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions
A Prospective, Multi-centre, Single Treatment Clinical Trial With Follow-up Investigations at 1, 4, 9, 12, 24 and 36 Months

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.

Not Provided
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
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.
Intervention: Device: ORSIRO - Drug Eluting Coronary Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2013
April 2010   (Final data collection date for primary outcome measure)

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%);
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Biotronik AG
Biotronik AG
Not Provided
Principal Investigator: Martial Hamon, MD Centre Hospitalier Universitaire Caen
Biotronik AG
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP