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To evaluate safety and clinical performance of the investigation product (drug-eluting absorbable metal stent system)
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Ethical review
Approved WMO
Status
Completed
Health condition type
Coronary artery disorders
Study type
Interventional
Source
ToetsingOnline
Brief title
BIOSOLVE-I Study
Condition
- Coronary artery disorders
Synonym
coronary stenosis, narrowing of the vessels (arteries) which supply the heart with blood
Research involving
Human
Sponsors and support
Primary sponsor :
Biotronik AG
Source(s) of monetary or material Support :
De sponsor van het onderzoek
Intervention
Keyword :
Absorbable, Coronary, Drug-Eluting, Stent
Outcome measures
Primary outcome
The primary endpoint of the study is MACE* at 6 month follow-up for cohort 1
and at 12 months follow-up for cohort 2.
*composite of cardiac death, myocardial infarction, clinically driven target
lesion revascularization
Secondary outcome
In-stent late lumen loss at 6 / 12 months (depending on patient cohort)
In-segment late lumen loss at 6 / 12 months (depending on patient cohort)
Percent in-stent diameter restenosis at 6 / 12 months (depending on patient
cohort)
Percent in-segment diameter restenosis at 6 / 12 months (depending on patient
cohort)
Binary in-stent restenosis at 6 / 12 months (depending on patient cohort)
Binary in-segment restenosis at 6 / 12 months (depending on patient cohort)
For both cohorts:
Cumulative MACE* rate at 1, 6, 12, 24 and 36 months
(*composite of cardiac death, myocardial infarction, clinically driven Target
Lesion Revascularization)
Stent thrombosis rate
Device success
Procedural success
Background summary
Stent placement is a common practise in cardiovascular intervention. There is a
lot of experience and clinical evidence with balloon cathethers, bare metal
stents and drug-eluting stents. There are also some running studies
investigating bioabsorbale stents. Our investigational product is a
drug-eluting absorbable metal stent and the goal of this first in man study is
to evaluate safety and clinical performance of this new stent technology in
humans.
Study objective
To evaluate safety and clinical performance of the investigation product
(drug-eluting absorbable metal stent system)
Study design
A prospective, multi-centre, first in man trial with follow-up investigations
at 1, 6, 12, 24 and 36 months
Intervention
Percutanous Coronary Intervention with stent placement
Study burden and risks
The study has the goal to prove safety of the device in humans. Although animal
data showed safety and all possible risk mitigation measures have been taken
there are remaining risks, e.g. the risk to have a thrombosis due to stent
fragments (caused by the degradation process). As this is a new technology
there is also the risk that clinical performance is not as expected. The risk
to have a reintervention due to restenosis of the same area is given. Risks are
also associate the with additional invasive image follow-up. These risks are
the same as for each intervention and not related to the investigational
device.
This new technology would provide certain benefits, e.g. easy re-intervention
if clinically needed as no metal or polymer is left behind, possible (to be
proven) shorter dual antiplatelet therapy.
The burden to the patient could be the number of follow-up visits (five) and
the required invasive image follow-ups. However, this is a first in man trial
and the follow-up visits are for the patient*s safety. The image follow-up will
help to see whether the treated area is still free of narrowing. In case of
re-narrowing, re-treatment can be done immediately.
Public
Biotronik AG
Ackerstrasse 6
8180 Bülach
CH
Scientific
Biotronik AG
Ackerstrasse 6
8180 Bülach
CH
Listed location countries
Netherlands
Age
Adults (18-64 years)
Elderly (65 years and older)
Inclusion criteria
1. Patient is between >/= 18 year and 2. Written patient informed consent available prior to PCI
3. Patients with stable or unstable angina pectoris or documented silent ischemia
4. Patient eligible for PCI
5. Patient acceptable candidate for coronary artery bypass surgery
6. Patients with a maximum of two lesions in two separate coronary arteries which have to be de novo lesions.
7. Target reference vessel diameter by visual estimation, assisted by QCA / IVUS: 3.0 - 3.5 mm
8. Target lesion length by visual estimation, assisted by QCA / IVUS: 9. Target lesion stenosis by visual estimation, assisted by QCA / IVUS: >/= 50% - < 100%
Exclusion criteria
1. Left ventricular ejection fraction of < 30%
2. Patients with three-vessel where all three vessels require treatment
3. Myocardial infarction (STEMI/NSTEMI) within 4 weeks of the intended treatment. Determination of CKMB and/or troponin T or I is required.
Notes:
Laboratory assessments to be done within 24 hours prior to intervention.
Patients with CKMB and/or troponin T or I > 3 fold the upper limit of normal must not be included in the trial.
4. Patients with risk of either acetylsalicylic acid, clopidogrel or Prasugrel cessation
5. Impaired renal function (serum creatinine > 2.0mg/dl or 177 umol/l, determined within 72 hours prior to intervention)
6. Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment
7. Lesions located within arterial or venous graft
8. Ostial lesions
Design
Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment
Recruitment
NL
Recruitment status
:
Completed
Start date (anticipated) :
Enrollment :
10
Type :
Actual
Medical products/devices used
Generic name :
Medical device called Drug-Eluting Absorbable Metal Stent (AMS-3.0) Coronary Stent System
Registration
:
No
Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32563.060.10 |
