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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01214148
First received: September 30, 2010
Last updated: August 8, 2013
Last verified: August 2013

September 30, 2010
August 8, 2013
July 2009
April 2010   (final data collection date for primary outcome measure)
In-stent Late Lumen Loss [ Time Frame: 9 months post procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01214148 on ClinicalTrials.gov Archive Site
  • In-stent and in-segment binary restenosis rate [ Time Frame: 4 and 9 months post procedure. ] [ Designated as safety issue: No ]
  • In-stent and in-segment (proximal and distal) minimum lumen diameter [ Time Frame: 4 and 9 months post-procedure ] [ Designated as safety issue: No ]
  • In-segment late lumen loss [ Time Frame: 4 and 9 months post procedure ] [ Designated as safety issue: No ]
  • In-stent late lumen loss [ Time Frame: 4 months post procedure. ] [ Designated as safety issue: No ]
  • Target Lesion Revascularization [ Time Frame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure ] [ Designated as safety issue: Yes ]
  • Clinically driven target lesion revascularization [ Time Frame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure ] [ Designated as safety issue: Yes ]
  • Target Vessel Revascularization [ Time Frame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure ] [ Designated as safety issue: Yes ]
  • - 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 ] [ Designated as safety issue: Yes ]
  • - Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels [ Time Frame: 3 years post procedure ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 1, 4 and 9 months and 1, 2 and 3 years post-procedure ] [ Designated as safety issue: Yes ]
  • Neointimal hyperplasia volume (subgroup) [ Time Frame: 4 and 9 months post-procedure measured by Intravascular Ultrasound (IVUS) ] [ Designated as safety issue: No ]
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
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
ORSIRO
Intervention: Device: ORSIRO - Drug Eluting Coronary Stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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%);
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT01214148
C0904
Yes
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