de Novo Lesions in Native Coronary ArteriesBIOSOLVE-INCT01168830
First in Man Trial - BIOSOLVE-I
A study testing AMS-3.0 in people with de Novo Lesions in Native Coronary Arteries, run by Biotronik AG at 6 sites in 4 countries.
Trial summary
First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- de Novo Lesions in Native Coronary Arteries
- What is being tested?
- AMS-3.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Jul 2010to Dec 2014
- Phase
- Interventional
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is > 18 years and < 80 years of age
- Written patient informed consent available prior to PCI
- Patients with stable or unstable angina pectoris or documented silent ischemia
- Patient eligible for PCI
- Patient acceptable candidate for coronary artery bypass surgery
Who cannot join
- Left ventricular ejection fraction of < 30%
- Presence of a visible thrombus in the target vessel visualized by angiography
- Lesion and/or way to lesion extremely calcified (e.g. IVUS catheter can not reach/cross the lesion)
- Patients with three-vessel where all three vessels require treatment
- Patients with previous CABG in the target vessel(s)
- Patients with known coronary artery spasm
Show all 24Show fewer
- Myocardial infarction (STEMI/NSTEMI) within 4 weeks of the intended treatment. Determination of CKMB and/or troponin T or I is required.
- Patients with planned major surgery within 12 months after coronary intervention
- Patients with risk of either acetylsalicylic acid, clopidogrel or Prasugrel cessation
- Patients under current Phenprocoumon or Cumarine therapy
- Impaired renal function (serum creatinine > 2.0mg/dl or 177micromol/l, determined within 72 hours prior to intervention)
- Additional coronary lesions (restenotic or de novo) in the same vessel which requires treatment
- Totally occluded coronary artery (TIMI flow 0)
- Lesions located within arterial or venous graft
- Ostial lesions
- Previous and/or planned brachytherapy of target vessel
- Target lesion located in left main coronary artery
- Stroke or TIA < 6 months prior to procedure
- Patient with signs of a cardiogenic shock
- Surgeries of any kind within 30 days prior to screening
- Patient with bleeding diathesis in whom anticoagulation or antiplatelet medication is contraindicated
- Pregnant and/or breast-feeding females or females who intend to become pregnant
- Patient currently enrolled in other investigational device or drug trial
- Patient with expected incompliance to medical (antiplatelet, anticoagulation) therapy
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Germany3 sites
Universitätsklinik Essen, Westdeutsches Herzzentrum
Essen
Universitätsklinikum Freiburg
Freiburg im Breisgau
Lukaskrankenhaus Neuss
Neuss
About this study
Official title: BIOTRONIKS-Safety and Clinical Performance Of the First Drug-Eluting Generation Absorbable Metal Stent In Patients With de Novo Lesions in NatiVE Coronary Arteries (BIOSOLVE - I)
First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety
- Being tested
- AMS-3.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMS-3.0Device
| Study group | Role | What they receive |
|---|---|---|
| Investigational device | Experimental | Not described Receives: Device: AMS-3.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for de Novo Lesions in Native Coronary ArteriesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168830
- Sponsor's protocol ID
- C1007
- Acronym
- BIOSOLVE-I
- Status last verified
- Feb 2015
- First submitted
- 22 Jul 2010
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Waksman R, Prati F, Bruining N, Haude M, Bose D, Kitabata H, Erne P, Verheye S, Degen H, Vermeersch P, Di Vito L, Koolen J, Erbel R. Serial observation of drug-eluting absorbable metal scaffold: multi-imaging modality assessment. Circ Cardiovasc Interv. 2013 Dec;6(6):644-53. doi: 10.1161/CIRCINTERVENTIONS.113.000693. Epub 2013 Nov 19.
PubMed 24254708Haude M, Erbel R, Erne P, Verheye S, Degen H, Bose D, Vermeersch P, Wijnbergen I, Weissman N, Prati F, Waksman R, Koolen J. Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial. Lancet. 2013 Mar 9;381(9869):836-44. doi: 10.1016/S0140-6736(12)61765-6.
PubMed 23332165
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOTRONIKS-Safety and Clinical Performance Of the First Drug-Eluting Generation Absorbable Metal Stent In Patients With de Novo Lesions in NatiVE Coronary Arteries (BIOSOLVE - I)
- ClinicalTrials.gov ID
- NCT01168830
- Acronym / sponsor ID
- BIOSOLVE-I / C1007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Jul 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.
First in Man Trial with the drug eluting absorbable metal scaffold. To assess safety
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational device | Experimental | Device: AMS-3.0 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is > 18 years and < 80 years of age
- Written patient informed consent available prior to PCI
- Patients with stable or unstable angina pectoris or documented silent ischemia
- Patient eligible for PCI
- Patient acceptable candidate for coronary artery bypass surgery
Key exclusion criteria (24 listed)
- Left ventricular ejection fraction of < 30%
- Presence of a visible thrombus in the target vessel visualized by angiography
- Lesion and/or way to lesion extremely calcified (e.g. IVUS catheter can not reach/cross the lesion)
- Patients with three-vessel where all three vessels require treatment
- Patients with previous CABG in the target vessel(s)
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 |
|---|---|---|
| AMS-3.0 | Device | Investigational device |
Primary outcome
Target Lesion Failure
Time frame: 6 and 12 months
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 5 Feb 2015.
- Derived from this study: PubMed 24254708Waksman R, Prati F, Bruining N, Haude M, Bose D, Kitabata H, Erne P, Verheye S, Degen H, Vermeersch P, Di Vito L, Koolen J, Erbel R. Serial observation of drug-eluting absorbable metal scaffold: multi-imaging modality assessment. Circ Cardiovasc Interv. 2013 Dec;6(6):644-53. doi: 10.1161/CIRCINTERVENTIONS.113.000693. Epub 2013 Nov 19.
- Derived from this study: PubMed 23332165Haude M, Erbel R, Erne P, Verheye S, Degen H, Bose D, Vermeersch P, Wijnbergen I, Weissman N, Prati F, Waksman R, Koolen J. Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial. Lancet. 2013 Mar 9;381(9869):836-44. doi: 10.1016/S0140-6736(12)61765-6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMS-3.0 in people with de Novo Lesions in Native Coronary Arteries, run by Biotronik AG at 6 sites in 4 countries.
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 5 inclusion and 24 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 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Belgium, Netherlands, Switzerland. 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.
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?
Target Lesion Failure (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01168830, which also lists 2 linked publications.
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 5 Feb 2015.