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CompletedNCT01214148BIOFLOW-IUpdated Aug 12, 2013

First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions

A Phase 1/2 interventional study of ORSIRO - Drug Eluting Coronary Stent in Coronary Artery Disease, sponsored by Biotronik AG. Completed at 2 sites in Romania. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-08-12.

Sponsored by Biotronik AG · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 30 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Biotronik AG is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

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%);
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    ORSIRO

    Device: ORSIRO - Drug Eluting Coronary Stent

Interventions

  • DeviceORSIRO - 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.

06

What researchers measure

Primary outcomes

  1. In-stent Late Lumen Loss

    Time frame: 9 months post procedure

Secondary outcomes

  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)

07

Study locations

2 sites
  • Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu" - Spitalul Clinic Fundeni
    Bucharest, Romania
  • Spitalul Clinic de Urgenţă Bucureşti
    Bucharest, Romania
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01214148
Lead sponsor
Biotronik AG
Responsible party
Sponsor
First posted
Oct 4, 2010
Start date
Jul 2009
Primary completion
Apr 2010
Completion
Jul 2013
Last update
Aug 12, 2013

Study contacts

Martial Hamon, MD
principal investigator · Centre Hospitalier Universitaire Caen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.

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