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
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: ORSIRO - Drug Eluting Coronary Stent
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • In-stent Late Lumen Loss [ Time Frame: 9 months post procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: July 2009
Study Completion Date: July 2013
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%);
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214148

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

No publications provided

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01214148     History of Changes
Other Study ID Numbers: C0904
Study First Received: September 30, 2010
Last Updated: August 8, 2013
Health Authority: Romania: Ministry of Public Health

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

ClinicalTrials.gov processed this record on September 22, 2014