Coronary Artery DiseasePhase 1/2BIOFLOW-INCT01214148
First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions
A Phase 1/2 study testing ORSIRO - Drug Eluting Coronary Stent in people with Coronary Artery Disease, run by Biotronik AG at 2 sites in Romania.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- ORSIRO - Drug Eluting Coronary Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesRomania
- Study dates
- Jul 2009to Jul 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 15Show fewer
- 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%);
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu" - Spitalul Clinic Fundeni
Bucharest
Spitalul Clinic de Urgenţă Bucureşti
Bucharest
About this study
Official title: 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.
- Conditions
- Coronary Artery Disease
- Being tested
- ORSIRO - Drug Eluting Coronary Stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORSIRO - Drug Eluting Coronary StentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ORSIRO | Other | Not described Receives: Device: ORSIRO - Drug Eluting Coronary Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent Late Lumen Loss
Measured: 9 months post procedure
Secondary outcomes (11)
In-stent and in-segment binary restenosis rate
Measured: 4 and 9 months post procedure.
In-stent and in-segment (proximal and distal) minimum lumen diameter
Measured: 4 and 9 months post-procedure
In-segment late lumen loss
Measured: 4 and 9 months post procedure
In-stent late lumen loss
Measured: 4 months post procedure.
Target Lesion Revascularization
Measured: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure
Clinically driven target lesion revascularization
Measured: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure
Target Vessel Revascularization
Measured: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure
- Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization
Measured: 1, 4 and 9 month post-procedure, and yearly up to 3 years
- Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels
Measured: 3 years post procedure
Stent thrombosis
Measured: 1, 4 and 9 months and 1, 2 and 3 years post-procedure
Neointimal hyperplasia volume (subgroup)
Measured: 4 and 9 months post-procedure measured by Intravascular Ultrasound (IVUS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startJul 2009
- Primary completionApr 2010
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martial Hamon, MD, Principal investigator, Centre Hospitalier Universitaire de Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214148
- Sponsor's protocol ID
- C0904
- Acronym
- BIOFLOW-I
- Status last verified
- Aug 2013
- First submitted
- 30 Sep 2010
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-centre, Single Treatment Clinical Trial With Follow-up Investigations at 1, 4, 9, 12, 24 and 36 Months
- ClinicalTrials.gov ID
- NCT01214148
- Acronym / sponsor ID
- BIOFLOW-I / C0904
- Conditions
- Coronary Artery Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 4 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ORSIRO | Other | Device: ORSIRO - Drug Eluting Coronary Stent |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORSIRO - Drug Eluting Coronary StentThe 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. | Device | ORSIRO |
Primary outcome
In-stent Late Lumen Loss
Time frame: 9 months post procedure
11 secondary outcomes
In-stent and in-segment binary restenosis rate
Time frame: 4 and 9 months post procedure.
In-stent and in-segment (proximal and distal) minimum lumen diameter
Time frame: 4 and 9 months post-procedure
In-segment late lumen loss
Time frame: 4 and 9 months post procedure
In-stent late lumen loss
Time frame: 4 months post procedure.
Target Lesion Revascularization
Time frame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure
Clinically driven target lesion revascularization
Time frame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure
Target Vessel Revascularization
Time frame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure
- 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
- Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels
Time frame: 3 years post procedure
Stent thrombosis
Time frame: 1, 4 and 9 months and 1, 2 and 3 years post-procedure
Neointimal hyperplasia volume (subgroup)
Time frame: 4 and 9 months post-procedure measured by Intravascular Ultrasound (IVUS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martial Hamon, MD principal investigator
Centre Hospitalier Universitaire de Caen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ORSIRO - Drug Eluting Coronary Stent in people with Coronary Artery Disease, run by Biotronik AG at 2 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent Late Lumen Loss (time frame: 9 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.