Coronary Artery DiseaseBIOSOLVE-IINCT01960504
First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)
A study testing Percutaneous Coronary Intervention (DREAMS) stenting in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Biotronik AG at 13 sites in 8 countries.
Trial summary
BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Stenosis
- What is being tested?
- Percutaneous Coronary Intervention (DREAMS) stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 13 sitesin 8 countries
- Study dates
- Oct 2013to May 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is > 18 years and < 80 years of age
- Written subject informed consent available prior to PCI
- Subjects with stable or unstable angina pectoris or documented silent ischemia
- Subject eligible for PCI
- Subject acceptable candidate for coronary artery bypass surgery
- Subjects with a maximum of two single lesions in two separate coronary arteries which have to be de novo lesions.
Show all 10Show fewer
- Reference vessel diameter between 2.2-3.8 mm by visual estimation
- Target lesion length ≤ 21 mm by visual estimation
- Target lesion stenosis by visual estimation, assisted by QCA / IVUS: > 50% - < 100%
- Eligible for Dual Anti Platelet Therapy (DAPT)
Who cannot join
- Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
- Evidence of myocardial infarction within 72 hours prior to index procedure
- Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the procedure
- Unprotected left main coronary artery disease
- Three-vessel coronary artery disease at time of procedure
- Thrombus in target vessel
Show all 23Show fewer
- Subject is currently participating in another study with an investigational device or an investigational drug and has not reached the primary endpoint yet
- Planned interventional treatment of any non-target vessel within 30 days post-procedure
- Subjects on dialysis
- Planned intervention of the target vessel within 6-month after the index procedure
- Ostial target lesion (within 5.0 mm of vessel origin)
- Target lesion involves a side branch >2.0 mm in diameter
- Documented left ventricular ejection fraction (LVEF) ≤ 30%
- Heavily calcified lesion
- Target lesion is located in or supplied by an arterial or venous bypass graft
- The target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to, rotational atherectomy, cutting balloon etc.)
- Known allergies to: Acetylsalicylic Acid (ASA), Heparin, Contrast medium, Sirolimus, or similar drugs; or the scaffold material
- Impaired renal function (serum creatinine > 2.5 mg/dl or 221 mmol/l, determined within 72 hours prior to intervention)
- Subject is receiving oral or intravenous immuno-suppressive therapy (e.g., inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
- Proximal or distal to the target lesion located stenosis that might require future revascularization or impede run off detected during diagnostic angiography
- Life expectancy less than 1 year
- Planned surgery or dental surgical procedure within 6 months after index procedure
- In the investigators opinion subjects will not be able to comply with the follow-up requirements
Trial locations and contacts
13 sites in 8 countries.
13 sites in 8 countries
Germany4 sites
Universitäts-Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, 79189
Segeberg Kliniken GmbH, Herzzentrum
Bad Segeberg, D-23795
Vivantes Klinikum
Berlin
Städtische Kliniken Neuss - Lukaskrankenhaus
Neuss, 41464
Brazil2 sites
Instituto Dante Pazzanese de Cardiologia
São Paulo, 04012-909
Instituto do Coração - HCFMUSP
São Paulo, 05403-000
Switzerland2 sites
University Hospital Basel
Basel, CH-4031
CHUV - Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
About this study
Official title: BIOTRONIK - Safety and Clinical PerFormance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects With de NOvo Lesions in NatiVE Coronary Arteries: BIOSOLVE-II
BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis
- Being tested
- Percutaneous Coronary Intervention (DREAMS) stenting
- Keywords
- DREAMS, Drug Eluting Absorbable Metal Scaffold, Scaffold, Coronary Artery Disease, Myocardial Ischemia, Atherosclerosis
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis, Myocardial Ischemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention (DREAMS) stentingDevice
Also called DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold
| Study group | Role | What they receive |
|---|---|---|
| Drug Eluting Absorbable Metal Scaffold | Experimental | DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold Receives: Device: Percutaneous Coronary Intervention (DREAMS) stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
In segment Late Lumen Loss
Measured: 6 months post index procedure
Secondary outcomes (8)
Target Lesion Failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularisation (TLR)
Measured: 1, 6, 12, 24 and 36 months
Scaffold thrombosis rate
Measured: 1, 6, 12, 24 and 36 months
In-scaffold and in-segment Binary Restenosis Rate
Measured: 6 and 12 months
In-scaffold and in-segment Percent Diameter Stenosis
Measured: 6 and 12 months
Late Lumen Loss in segment
Measured: 12 months
Late Lumen Loss in scaffold
Measured: 6 and 12 months
Procedure success
Procedure Success defined as achievement of a final diameter stenosis of <30% by QCA, using any percutaneous method, without the occurrence of death, Q-wave or WHO defined non-Q-wave, or repeat revascularization of the target lesion during the hospital stay.
Measured: During the hospital stay to a maximum of the first seven days post index procedure
Device success
Device Success is defined as a final residual diameter stenosis of <30% by QCA, using the assigned device only
- successful delivery of the scaffold to the target lesion site in the coronary artery
- appropriate scaffold deployment
- successful removal of the device
- safe removal of the device in case of deployment failure
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionAug 2015
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Haude, MD, Principal investigator, Städtische Kliniken Neuss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960504
- Sponsor's protocol ID
- C1209
- Acronym
- BIOSOLVE-II
- Status last verified
- Jan 2020
- First submitted
- 6 Oct 2013
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beyene S, Tufaro V, Garg M, Gkargkoulas F, Calderon AT, Safi H, Waksman R, Windecker S, Torii R, Melaku GD, Bulant CA, Bourantas CV, Blanco PJ, Garcia-Garcia HM. Comparison of endothelial shear stress between ultrathin strut bioresorbable polymer drug-eluting stent vs durable-polymer drug-eluting stent post-stent implantation: An optical coherence tomography substudy from BIOFLOW II. Cardiovasc Revasc Med. 2024 Apr;61:26-34. doi: 10.1016/j.carrev.2023.11.014. Epub 2023 Nov 25.
PubMed 38042738Ozaki Y, Kuku KO, Sakellarios A, Haude M, Hideo-Kajita A, Desale S, Siogkas P, Sioros S, Ince H, Abizaid A, Tolg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Escaned J, Michalis L, Fotiadis DI, Djikstra J, Waksman R, Garcia-Garcia HM. Impact of Endothelial Shear Stress on Absorption Process of Resorbable Magnesium Scaffold: A BIOSOLVE-II Substudy. Cardiovasc Revasc Med. 2021 Aug;29:9-15. doi: 10.1016/j.carrev.2021.04.003. Epub 2021 Apr 9.
PubMed 33863661Ueki Y, Raber L, Otsuka T, Rai H, Losdat S, Windecker S, Garcia-Garcia HM, Landmesser U, Koolen J, Byrne R, Haude M, Joner M. Mechanism of Drug-Eluting Absorbable Metal Scaffold Restenosis: A Serial Optical Coherence Tomography Study. Circ Cardiovasc Interv. 2020 Mar;13(3):e008657. doi: 10.1161/CIRCINTERVENTIONS.119.008657. Epub 2020 Feb 25.
PubMed 32093514Ozaki Y, Garcia-Garcia HM, Hideo-Kajita A, Kuku KO, Haude M, Ince H, Abizaid A, Tolg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Escaned J, Waksman R. Serial 3-Dimensional Optical Coherence Tomography Assessment of Jailed Side-Branch by Second-Generation Drug-Eluting Absorbable Metal Scaffold (from the BIOSOLVE-II Trial). Am J Cardiol. 2019 Apr 1;123(7):1044-1051. doi: 10.1016/j.amjcard.2018.12.029. Epub 2019 Jan 4.
PubMed 30683424Garcia-Garcia HM, Haude M, Kuku K, Hideo-Kajita A, Ince H, Abizaid A, Tolg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Escaned J, Dijkstra J, Waksman R. In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris - DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial. Int J Cardiol. 2018 Mar 15;255:22-28. doi: 10.1016/j.ijcard.2017.12.053. Epub 2017 Dec 28.
PubMed 29292064Haude M, Ince H, Abizaid A, Toelg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Neumann FJ, Kaiser C, Eeckhout E, Lim ST, Escaned J, Onuma Y, Garcia-Garcia HM, Waksman R. Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. Eur Heart J. 2016 Sep 14;37(35):2701-9. doi: 10.1093/eurheartj/ehw196. Epub 2016 May 17.
PubMed 27190094Haude M, Ince H, Abizaid A, Toelg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Neumann FJ, Kaiser C, Eeckhout E, Lim ST, Escaned J, Garcia-Garcia HM, Waksman R. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet. 2016 Jan 2;387(10013):31-9. doi: 10.1016/S0140-6736(15)00447-X. Epub 2015 Oct 12.
PubMed 26470647
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIOTRONIK - Safety and Clinical PerFormance of the Drug Eluting Absorbable Metal Scaffold (DREAMS 2nd Generation) in the Treatment of Subjects With de NOvo Lesions in NatiVE Coronary Arteries: BIOSOLVE-II
- ClinicalTrials.gov ID
- NCT01960504
- Acronym / sponsor ID
- BIOSOLVE-II / C1209
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis
- Keywords
- DREAMS, Drug Eluting Absorbable Metal Scaffold, Scaffold, Coronary Artery Disease, Myocardial Ischemia, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Biotronik AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2013 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- May 2020 (estimated)
- First posted
- 10 Oct 2013 (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.
BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug Eluting Absorbable Metal Scaffold | Experimental | Device: Percutaneous Coronary Intervention (DREAMS) stentingDREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is > 18 years and < 80 years of age
- Written subject informed consent available prior to PCI
- Subjects with stable or unstable angina pectoris or documented silent ischemia
- Subject eligible for PCI
- Subject acceptable candidate for coronary artery bypass surgery
Key exclusion criteria (23 listed)
- Pregnant or breast-feeding females or females who intend to become pregnant during the time of the study
- Evidence of myocardial infarction within 72 hours prior to index procedure
- Subjects with a ≥2 fold CK level or in absence of CK a ≥3 fold CKMB level above the upper range limit within 24 hours prior to the procedure
- Unprotected left main coronary artery disease
- Three-vessel coronary artery disease at time of procedure
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 |
|---|---|---|
| Percutaneous Coronary Intervention (DREAMS) stentingAlso: DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold | Device | Drug Eluting Absorbable Metal Scaffold |
Primary outcome
In segment Late Lumen Loss
Time frame: 6 months post index procedure
8 secondary outcomes
Target Lesion Failure (TLF), defined as composite of cardiac death, target vessel Q-wave or non-Q-wave Myocardial Infarction (MI), Coronary Artery Bypass Graft (CABG), clinically driven Target Lesion Revascularisation (TLR)
Time frame: 1, 6, 12, 24 and 36 months
Scaffold thrombosis rate
Time frame: 1, 6, 12, 24 and 36 months
In-scaffold and in-segment Binary Restenosis Rate
Time frame: 6 and 12 months
In-scaffold and in-segment Percent Diameter Stenosis
Time frame: 6 and 12 months
Late Lumen Loss in segment
Time frame: 12 months
Late Lumen Loss in scaffold
Time frame: 6 and 12 months
Procedure success
Time frame: During the hospital stay to a maximum of the first seven days post index procedure
Device success
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 38042738Beyene S, Tufaro V, Garg M, Gkargkoulas F, Calderon AT, Safi H, Waksman R, Windecker S, Torii R, Melaku GD, Bulant CA, Bourantas CV, Blanco PJ, Garcia-Garcia HM. Comparison of endothelial shear stress between ultrathin strut bioresorbable polymer drug-eluting stent vs durable-polymer drug-eluting stent post-stent implantation: An optical coherence tomography substudy from BIOFLOW II. Cardiovasc Revasc Med. 2024 Apr;61:26-34. doi: 10.1016/j.carrev.2023.11.014. Epub 2023 Nov 25.
- Derived from this study: PubMed 33863661Ozaki Y, Kuku KO, Sakellarios A, Haude M, Hideo-Kajita A, Desale S, Siogkas P, Sioros S, Ince H, Abizaid A, Tolg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Escaned J, Michalis L, Fotiadis DI, Djikstra J, Waksman R, Garcia-Garcia HM. Impact of Endothelial Shear Stress on Absorption Process of Resorbable Magnesium Scaffold: A BIOSOLVE-II Substudy. Cardiovasc Revasc Med. 2021 Aug;29:9-15. doi: 10.1016/j.carrev.2021.04.003. Epub 2021 Apr 9.
- Derived from this study: PubMed 32093514Ueki Y, Raber L, Otsuka T, Rai H, Losdat S, Windecker S, Garcia-Garcia HM, Landmesser U, Koolen J, Byrne R, Haude M, Joner M. Mechanism of Drug-Eluting Absorbable Metal Scaffold Restenosis: A Serial Optical Coherence Tomography Study. Circ Cardiovasc Interv. 2020 Mar;13(3):e008657. doi: 10.1161/CIRCINTERVENTIONS.119.008657. Epub 2020 Feb 25.
- Derived from this study: PubMed 30683424Ozaki Y, Garcia-Garcia HM, Hideo-Kajita A, Kuku KO, Haude M, Ince H, Abizaid A, Tolg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Escaned J, Waksman R. Serial 3-Dimensional Optical Coherence Tomography Assessment of Jailed Side-Branch by Second-Generation Drug-Eluting Absorbable Metal Scaffold (from the BIOSOLVE-II Trial). Am J Cardiol. 2019 Apr 1;123(7):1044-1051. doi: 10.1016/j.amjcard.2018.12.029. Epub 2019 Jan 4.
- Derived from this study: PubMed 29292064Garcia-Garcia HM, Haude M, Kuku K, Hideo-Kajita A, Ince H, Abizaid A, Tolg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Escaned J, Dijkstra J, Waksman R. In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris - DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial. Int J Cardiol. 2018 Mar 15;255:22-28. doi: 10.1016/j.ijcard.2017.12.053. Epub 2017 Dec 28.
- Derived from this study: PubMed 27190094Haude M, Ince H, Abizaid A, Toelg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Neumann FJ, Kaiser C, Eeckhout E, Lim ST, Escaned J, Onuma Y, Garcia-Garcia HM, Waksman R. Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. Eur Heart J. 2016 Sep 14;37(35):2701-9. doi: 10.1093/eurheartj/ehw196. Epub 2016 May 17.
- Derived from this study: PubMed 26470647Haude M, Ince H, Abizaid A, Toelg R, Lemos PA, von Birgelen C, Christiansen EH, Wijns W, Neumann FJ, Kaiser C, Eeckhout E, Lim ST, Escaned J, Garcia-Garcia HM, Waksman R. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet. 2016 Jan 2;387(10013):31-9. doi: 10.1016/S0140-6736(15)00447-X. Epub 2015 Oct 12.
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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.
Michael Haude, MD principal investigator
Städtische Kliniken Neuss
13 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention (DREAMS) stenting in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Biotronik AG at 13 sites in 8 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 10 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Brazil, Switzerland, Belgium, Denmark and 3 more countries. 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?
Results are not available in the source record.
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 segment Late Lumen Loss (time frame: 6 months post index procedure). 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 NCT01960504, which also lists 7 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 18 Jan 2020.