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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 1

Locations

Romania

Study Type

Interventional

Intervention

ORSIRO - Drug Eluting Coronary Stent

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient is ≥18 years old;
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;
Single de novo lesion with ≥50% and <90% stenosis in 1 coronary artery;

Exclusion Criteria:

Documented left ventricular ejection fraction (LVEF) ≤30%;
Unstable angina pectoris(Braunwald Class A I-III)
Three-vessel coronary artery disease
Evidence of myocardial infarction within 72 hours prior to the index procedure;
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)
A platelet count <100.000 cells/mm3 or >700.000 cells/mm3 or a WBC <3.000 cells/mm3;
Acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or >150µmol/L);
Total occlusion (TIMI 0 or 1);
Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment;
Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
Target lesion is located in or supplied by an arterial or venous bypass graft;
Ostial target lesion (within 5.0mm of vessel origin);
Target lesion involves a side branch >2.0mm in diameter;
Unprotected Left main coronary artery disease (stenosis >50%);

Sites / Locations

Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu" - Spitalul Clinic Fundeni
Spitalul Clinic de Urgenţă Bucureşti

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ORSIRO

Arm Description

Outcomes

Primary Outcome Measures

In-stent Late Lumen Loss

Secondary Outcome Measures

In-stent and in-segment binary restenosis rate

In-stent and in-segment (proximal and distal) minimum lumen diameter

In-segment late lumen loss

In-stent late lumen loss

Target Lesion Revascularization

Clinically driven target lesion revascularization

Target Vessel Revascularization

- Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization

- Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels

Stent thrombosis

Neointimal hyperplasia volume (subgroup)

Full Information

NCT ID

NCT01214148

First Posted

September 30, 2010

Last Updated

August 8, 2013

Sponsor

Biotronik AG

1. Study Identification

Unique Protocol Identification Number

NCT01214148

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biotronik AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ORSIRO

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

ORSIRO - Drug Eluting Coronary Stent

Intervention Description

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.

Primary Outcome Measure Information:

Title

In-stent Late Lumen Loss

Time Frame

9 months post procedure

Secondary Outcome Measure Information:

Title

In-stent and in-segment binary restenosis rate

Time Frame

4 and 9 months post procedure.

Title

In-stent and in-segment (proximal and distal) minimum lumen diameter

Time Frame

4 and 9 months post-procedure

Title

In-segment late lumen loss

Time Frame

4 and 9 months post procedure

Title

In-stent late lumen loss

Time Frame

4 months post procedure.

Title

Target Lesion Revascularization

Time Frame

1, 4 and 9 months and at 1, 2 and 3 years post-procedure

Title

Clinically driven target lesion revascularization

Time Frame

1, 4 and 9 months and at 1, 2 and 3 years post-procedure

Title

Target Vessel Revascularization

Time Frame

1, 4 and 9 months and at 1, 2 and 3 years post-procedure

Title

- 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

Title

- Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels

Time Frame

3 years post procedure

Title

Stent thrombosis

Time Frame

1, 4 and 9 months and 1, 2 and 3 years post-procedure

Title

Neointimal hyperplasia volume (subgroup)

Time Frame

4 and 9 months post-procedure measured by Intravascular Ultrasound (IVUS)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient is ≥18 years old; 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; Single de novo lesion with ≥50% and <90% stenosis in 1 coronary artery; Exclusion Criteria: Documented left ventricular ejection fraction (LVEF) ≤30%; Unstable angina pectoris(Braunwald Class A I-III) Three-vessel coronary artery disease Evidence of myocardial infarction within 72 hours prior to the index procedure; 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) A platelet count <100.000 cells/mm3 or >700.000 cells/mm3 or a WBC <3.000 cells/mm3; Acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or >150µmol/L); Total occlusion (TIMI 0 or 1); Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment; Significant (>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off; Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated; Target lesion is located in or supplied by an arterial or venous bypass graft; Ostial target lesion (within 5.0mm of vessel origin); Target lesion involves a side branch >2.0mm in diameter; Unprotected Left main coronary artery disease (stenosis >50%);

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martial Hamon, MD

Organizational Affiliation

Centre Hospitalier Universitaire Caen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu" - Spitalul Clinic Fundeni

City

Bucharest

Country

Romania

Facility Name

Spitalul Clinic de Urgenţă Bucureşti

City

Bucharest

Country

Romania

12. IPD Sharing Statement

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

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