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

Coronary Artery Disease Clinical Trial

— BIOFLOW-I  

Official title:

A Prospective, Multi-centre, Single Treatment Clinical Trial With Follow-up Investigations at 1, 4, 9, 12, 24 and 36 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214148
• Other study ID #: C0904
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 30, 2010
• Last updated: August 8, 2013
• Start date: July 2009
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Biotronik AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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%);

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Romania	Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu" - Spitalul Clinic Fundeni	Bucharest
Romania	Spitalul Clinic de Urgenta Bucuresti	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik AG

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent Late Lumen Loss		9 months post procedure	No
Secondary	In-stent and in-segment binary restenosis rate		4 and 9 months post procedure.	No
Secondary	In-stent and in-segment (proximal and distal) minimum lumen diameter		4 and 9 months post-procedure	No
Secondary	In-segment late lumen loss		4 and 9 months post procedure	No
Secondary	In-stent late lumen loss		4 months post procedure.	No
Secondary	Target Lesion Revascularization		1, 4 and 9 months and at 1, 2 and 3 years post-procedure	Yes
Secondary	Clinically driven target lesion revascularization		1, 4 and 9 months and at 1, 2 and 3 years post-procedure	Yes
Secondary	Target Vessel Revascularization		1, 4 and 9 months and at 1, 2 and 3 years post-procedure	Yes
Secondary	- Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization		1, 4 and 9 month post-procedure, and yearly up to 3 years	Yes
Secondary	- Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels		3 years post procedure	Yes
Secondary	Stent thrombosis		1, 4 and 9 months and 1, 2 and 3 years post-procedure	Yes
Secondary	Neointimal hyperplasia volume (subgroup)		4 and 9 months post-procedure measured by Intravascular Ultrasound (IVUS)	No