In-Stent Stenosis (Restenosis) of Coronary Artery StentBIOFLOW-ChinaNCT05667285
BIOFLOW-china Post-marketing Study (BIOTRONIK)
An observational study of In-Stent Stenosis (Restenosis) of Coronary Artery Stent and Native Coronary Artery Stenosis, run by Biotronik (Beijing) Medical Device Ltd. at 2 sites in China.
Trial summary
This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods. The goal of this study is to assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-Stent Stenosis (Restenosis) of Coronary Artery Stent, Native Coronary Artery Stenosis
- What is being tested?
- BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System
- Type of treatment
- Medical device
- How many people
- 122 participants
- Where
- 2 sitesChina
- Study dates
- 2 Jun 2023to 27 Sep 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The Sirolimus-eluting coronary stent system can improve the diameter of the coronary lumen. It is suitable for patients with ischemic heart disease symptoms caused by primary stenotic lesions and in-stent restenotic lesions (length ≤ 36 mm) dispersed within the native coronary arteries (reference vessel diameter of 2.25 mm to 4.0 mm).
Who may be able to join
- The subject should be 18 years or older when undergoing the procedure.
- The subject has signed the Informed Consent.
- The subject signed Informed Consent dated back within 12 months and was implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.
Who cannot join
- The subject has or had a life expectancy less then 12 month after treatment with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.
- The subject has any known allergies to the following substances: aspirin, heparin/divalerythromycin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), bivalirudin, rapamycin, L-605 cobalt-chromium (Co-Cr) alloy or its main elements (cobalt, chromium, tungsten and nickel), acrylic acid, fluoropolymer, silicon carbide, PLLA allergy or contraindications.
- The investigator judges that the subject has poor compliance and cannot complete the study as required, or other circumstances that are not suitable for participation in this study .
Trial locations and contacts
2 sites in 1 country.
China2 sites
The 4th Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Zhejiang University Mingzhou Hospital
Ningbo, Zhejiang, 310000
About this study
Official title: Chinese Post-marketing Clinical Study Project Protocol for Evaluate the Safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System
This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods.
The goal of this study is to assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in China.
Read the detailed description
This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods. A total of 2,000 subjects will be enrolled from up to 15 research sites in China. Suitable subjects will be selected according to the inclusion and exclusion criteria, and those who meet the inclusion and exclusion criteria will accept follow-up after signing the informed consent form from the site ethics committee until 5 years after surgery. It is aimed to further assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in China by observing the data collected in this trial.
- Being tested
- BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System
- Keywords
- Orsiro, BIOTRONIK, China, Coronary Stent System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent SystemDevice
During the procedure, the investigator assesses the arterial diameter and lesion length either visually or using QCA to select the appropriate stent. The number of stents required for each lesion is determined by the investigator based on the specific circumstances. The length of the stent should cover from the proximal normal reference vessel to the distal normal reference vessel, ensuring complete coverage of the lesion.
The number of stents required for each lesion is determined by the investigator based on the specific circumstances. If the first stent does not fully cover the lesion, a second or even more stents may be used. In such cases, the second or additional stents are selected by the investigator based on the specific circumstances, such as using Orsiro SES stents, unless clinically contraindicated or specifically required. Please refer to the stent's Instructions for Use for the procedure.
If stent overlap occurs, the overlapping part should be at least 2mm.
| Study group | Role | What they receive |
|---|---|---|
| BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System | Subject implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation. Receives: Device: BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure (TLF) at 1 years ± 60 days after surgery
Including cardiogenic death, target vessel Q-wave and non-Q-wave myocardial infarction, coronary artery bypass grafting (CABG), and clinically driven target lesion revascularization (TLR).
Measured: 1 years ± 60 days after surgery
Secondary outcomes (3)
Major adverse cardiac event (MACE) at 1, 2, 3, 4 and 5 years ± 60 days after surgery
Including all-cause deaths, Q-wave or non-Q-wave myocardial infarction, and clinically driven target lesion revascularizition (TLR).
Measured: 1, 2, 3, 4 and 5 years ± 60 days after surgery
Target lesion failure (TLF) at 2, 3, 4 and 5 years ± 60 days after surgery
Including cardiogenic death, target vessel Q-wave and non-Q-wave myocardial infarction, coronary artery bypass grafting (CABG), and clinically driven target lesion revascularization (TLR).
Measured: 2, 3, 4 and 5 years ± 60 days after surgery
Serious adverse device effects (SADEs)
A serious adverse device effect (SADE) refers to any adverse device event that leads to the consequences and characteristics of serious adverse events.
Measured: 1, 2, 3, 4 and 5 years ± 60 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start2 Jun 2023
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Why it stopped: According to the renewal registration certificate requirements issued by the NMPA, this product does not need to collect post-market safety data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for In-Stent Stenosis (Restenosis) of Coronary Artery StentStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik (Beijing) Medical Device Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biotronik AG
- Responsible party
- Sponsor
- Investigators
- Wei Yang, Principal investigator, The Fourth Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667285
- Sponsor's protocol ID
- C2022
- Acronym
- BIOFLOW-China
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2022
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The sponsor has exclusive ownership of the trial data and results. During the clinical trial process, the sponsor has the right to consult and use all the data and results obtained from the trial. Before the results of each site are published and/or reported, any single clinical trial site is not allowed to publish and/or report its results. The sponsor agrees that the principal investigator of the trial may publish the results of the clinical trial.
Publications
Li C, Yang Y, Han Y, Song D, Xu J, Guan C, Gao R, Garcia-Garcia HM, Waksman R, Xu B; BIOFLOW VI Trial Investigators. Comparison of the Ultrathin Strut, Biodegradable Polymer Sirolimus-eluting Stent With a Durable Polymer Everolimus-eluting Stent in a Chinese Population: The Randomized BIOFLOW VI Trial. Clin Ther. 2020 Apr;42(4):649-660.e9. doi: 10.1016/j.clinthera.2020.02.014. Epub 2020 Apr 5.
PubMed 32268942Kandzari DE, Koolen JJ, Doros G, Garcia-Garcia HM, Bennett J, Roguin A, Gharib EG, Cutlip DE, Waksman R; BIOFLOW V Investigators. Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization: 3-Year Outcomes From the Randomized BIOFLOW V Trial. JACC Cardiovasc Interv. 2020 Jun 8;13(11):1343-1353. doi: 10.1016/j.jcin.2020.02.019.
PubMed 32499026Saito S, Toelg R, Witzenbichler B, Haude M, Masotti M, Salmeron R, Witkowski A, Uematsu M, Takahashi A, Waksman R, Slagboom T. BIOFLOW-IV, a randomised, intercontinental, multicentre study to assess the safety and effectiveness of the Orsiro sirolimus-eluting stent in the treatment of subjects with de novo coronary artery lesions: primary outcome target vessel failure at 12 months. EuroIntervention. 2019 Dec 6;15(11):e1006-e1013. doi: 10.4244/EIJ-D-18-01214.
PubMed 31235458Hamon M, Niculescu R, Deleanu D, Dorobantu M, Weissman NJ, Waksman R. Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-man study. EuroIntervention. 2013 Jan 22;8(9):1006-11. doi: 10.4244/EIJV8I9A155.
PubMed 23339805Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M, van Leeuwen F, Windecker S. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010 Jul 8;363(2):136-46. doi: 10.1056/NEJMoa1004130. Epub 2010 Jun 16.
PubMed 20554978Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.
PubMed 18430909Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrie D, Thuesen L, Boone E, Miquel-Herbert K, Daemen J. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial. EuroIntervention. 2006 Nov;2(3):286-94.
PubMed 19755303Tsuchida K, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher AM, Grube E, Haase J, Thuesen L, Hamm CW, Veldhof S, Dorange C, Serruys PW. One-year results of a durable polymer everolimus-eluting stent in de novo coronary narrowings (The SPIRIT FIRST Trial). EuroIntervention. 2005 Nov;1(3):266-72.
PubMed 19758915Serruys PW, Ong AT, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher A, Grube E, Haase J, Thuesen L, Hamm C, Otto-Terlouw PC. A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial. EuroIntervention. 2005 May;1(1):58-65.
PubMed 19758878Tsuji T, Tamai H, Igaki K, Kyo E, Kosuga K, Hata T, Okada M, Nakamura T, Komori H, Motohara S, Uehata H. Biodegradable Polymeric Stents. Curr Interv Cardiol Rep. 2001 Feb;3(1):10-17.
PubMed 11177716Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8.
PubMed 18342684Grube E, Hauptmann KE, Buellesfeld L, Lim V, Abizaid A. Six-month results of a randomized study to evaluate safety and efficacy of a Biolimus A9 eluting stent with a biodegradable polymer coating. EuroIntervention. 2005 May;1(1):53-7.
PubMed 19758877Chevalier B, Serruys PW, Silber S, Garcia E, Suryapranata H, Hauptmann K, Wijns W, Schuler G, Fath-Ordoubadi F, Worthley S, Thuesen L, Meredith I, Bressers M, Nagai H, Paunovic D. Randomised comparison of Nobori, biolimus A9-eluting coronary stent with a Taxus(R), paclitaxel-eluting coronary stent in patients with stenosis in native coronary arteries: the Nobori 1 trial. EuroIntervention. 2007 Feb;2(4):426-34.
PubMed 19755281Carrie D, Khalife K, Citron B, Izaaz K, Hamon M, Juiliard JM, Leclercq F, Fourcade J, Lipiecki J, Sabatier R, Boulet V, Rinaldi JP, Mourali S, Fatouch M, El Mokhtar E, Aboujaoude G, Elbaz M, Grolleau R, Steg PG, Puel J; Benefit Evaluation of Direct Coronary Stenting Study Group. Comparison of direct coronary stenting with and without balloon predilatation in patients with stable angina pectoris. BET (Benefit Evaluation of Direct Coronary Stenting) Study Group. Am J Cardiol. 2001 Mar 15;87(6):693-8. doi: 10.1016/s0002-9149(00)01485-5.
PubMed 11249885Unverdorben M, Sattler K, Degenhardt R, Fries R, Abt B, Wagner E, Koehler H, Scholz M, Ibrahim H, Tews KH, Hennen B, Daemgen G, Berthold HK, Vallbracht C. Comparison of a silicon carbide coated stent versus a noncoated stent in humans: the Tenax- versus Nir-Stent Study (TENISS). J Interv Cardiol. 2003 Aug;16(4):325-33. doi: 10.1034/j.1600-6143.2003.08058.x.
PubMed 14562673
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Post-marketing Clinical Study Project Protocol for Evaluate the Safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System
- ClinicalTrials.gov ID
- NCT05667285
- Acronym / sponsor ID
- BIOFLOW-China / C2022
- Keywords
- Orsiro, BIOTRONIK, China, Coronary Stent System
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: According to the renewal registration certificate requirements issued by the NMPA, this product does not need to collect post-market safety data.
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Biotronik (Beijing) Medical Device Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Biotronik AG
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 28 Dec 2022 (actual)
- 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.
This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods.
The goal of this study is to assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in China.
Detailed description
This trial uses prospective, retrospective, observational, non-blinded, multi-center, single-arm, post-marketing hospital data collection and research methods. A total of 2,000 subjects will be enrolled from up to 15 research sites in China. Suitable subjects will be selected according to the inclusion and exclusion criteria, and those who meet the inclusion and exclusion criteria will accept follow-up after signing the informed consent form from the site ethics committee until 5 years after surgery. It is aimed to further assess the safety of BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in the Chinese patient population after marketing in China by observing the data collected in this trial.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System | – | Device: BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent SystemSubject implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The Sirolimus-eluting coronary stent system can improve the diameter of the coronary lumen. It is suitable for patients with ischemic heart disease symptoms caused by primary stenotic lesions and in-stent restenotic lesions (length ≤ 36 mm) dispersed within the native coronary arteries (reference vessel diameter of 2.25 mm to 4.0 mm).
Key inclusion criteria (3 listed)
- The subject should be 18 years or older when undergoing the procedure.
- The subject has signed the Informed Consent.
- The subject signed Informed Consent dated back within 12 months and was implanted with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.
Key exclusion criteria (3 listed)
- The subject has or had a life expectancy less then 12 month after treatment with BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System in stent implantation operation.
- The subject has any known allergies to the following substances: aspirin, heparin/divalerythromycin, P2Y12 inhibitors (clopidogrel/prasugrel/ticagrelor), bivalirudin, rapamycin, L-605 cobalt-chromium (Co-Cr) alloy or its main elements (cobalt, chromium, tungsten and nickel), acrylic acid, fluoropolymer, silicon carbide, PLLA allergy or contraindications.
- The investigator judges that the subject has poor compliance and cannot complete the study as required, or other circumstances that are not suitable for participation in this study .
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 |
|---|---|---|
| BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent SystemDuring the procedure, the investigator assesses the arterial diameter and lesion length either visually or using QCA to select the appropriate stent. The number of stents required for each lesion is determined by the investigator based on the specific circumstances. The length of the stent should cover from the proximal normal reference vessel to the distal normal reference vessel, ensuring complete coverage of the lesion. The number of stents required for each lesion is determined by the investigator based on the specific circumstances. If the first stent does not fully cover the lesion, a second or even more stents may be used. In such cases, the second or additional stents are selected by the investigator based on the specific circumstances, such as using Orsiro SES stents, unless clinically contraindicated or specifically required. Please refer to the stent's Instructions for Use for the procedure. If stent overlap occurs, the overlapping part should be at least 2mm. | Device | BIOTRONIK Orsiro Sirolimus-Eluting Coronary Stent System |
Primary outcome
Target lesion failure (TLF) at 1 years ± 60 days after surgery
Time frame: 1 years ± 60 days after surgery
Including cardiogenic death, target vessel Q-wave and non-Q-wave myocardial infarction, coronary artery bypass grafting (CABG), and clinically driven target lesion revascularization (TLR).
3 secondary outcomes
Major adverse cardiac event (MACE) at 1, 2, 3, 4 and 5 years ± 60 days after surgery
Time frame: 1, 2, 3, 4 and 5 years ± 60 days after surgery
Target lesion failure (TLF) at 2, 3, 4 and 5 years ± 60 days after surgery
Time frame: 2, 3, 4 and 5 years ± 60 days after surgery
Serious adverse device effects (SADEs)
Time frame: 1, 2, 3, 4 and 5 years ± 60 days after surgery
Results and safety
The study was stopped early (reason given: According to the renewal registration certificate requirements issued by the NMPA, this product does not need to collect post-market safety data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 32268942Li C, Yang Y, Han Y, Song D, Xu J, Guan C, Gao R, Garcia-Garcia HM, Waksman R, Xu B; BIOFLOW VI Trial Investigators. Comparison of the Ultrathin Strut, Biodegradable Polymer Sirolimus-eluting Stent With a Durable Polymer Everolimus-eluting Stent in a Chinese Population: The Randomized BIOFLOW VI Trial. Clin Ther. 2020 Apr;42(4):649-660.e9. doi: 10.1016/j.clinthera.2020.02.014. Epub 2020 Apr 5.
- Background: PubMed 32499026Kandzari DE, Koolen JJ, Doros G, Garcia-Garcia HM, Bennett J, Roguin A, Gharib EG, Cutlip DE, Waksman R; BIOFLOW V Investigators. Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents for Coronary Revascularization: 3-Year Outcomes From the Randomized BIOFLOW V Trial. JACC Cardiovasc Interv. 2020 Jun 8;13(11):1343-1353. doi: 10.1016/j.jcin.2020.02.019.
- Background: PubMed 31235458Saito S, Toelg R, Witzenbichler B, Haude M, Masotti M, Salmeron R, Witkowski A, Uematsu M, Takahashi A, Waksman R, Slagboom T. BIOFLOW-IV, a randomised, intercontinental, multicentre study to assess the safety and effectiveness of the Orsiro sirolimus-eluting stent in the treatment of subjects with de novo coronary artery lesions: primary outcome target vessel failure at 12 months. EuroIntervention. 2019 Dec 6;15(11):e1006-e1013. doi: 10.4244/EIJ-D-18-01214.
- Background: PubMed 23339805Hamon M, Niculescu R, Deleanu D, Dorobantu M, Weissman NJ, Waksman R. Clinical and angiographic experience with a third-generation drug-eluting Orsiro stent in the treatment of single de novo coronary artery lesions (BIOFLOW-I): a prospective, first-in-man study. EuroIntervention. 2013 Jan 22;8(9):1006-11. doi: 10.4244/EIJV8I9A155.
- Background: PubMed 20554978Serruys PW, Silber S, Garg S, van Geuns RJ, Richardt G, Buszman PE, Kelbaek H, van Boven AJ, Hofma SH, Linke A, Klauss V, Wijns W, Macaya C, Garot P, DiMario C, Manoharan G, Kornowski R, Ischinger T, Bartorelli A, Ronden J, Bressers M, Gobbens P, Negoita M, van Leeuwen F, Windecker S. Comparison of zotarolimus-eluting and everolimus-eluting coronary stents. N Engl J Med. 2010 Jul 8;363(2):136-46. doi: 10.1056/NEJMoa1004130. Epub 2010 Jun 16.
- Background: PubMed 18430909Stone GW, Midei M, Newman W, Sanz M, Hermiller JB, Williams J, Farhat N, Mahaffey KW, Cutlip DE, Fitzgerald PJ, Sood P, Su X, Lansky AJ; SPIRIT III Investigators. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: a randomized trial. JAMA. 2008 Apr 23;299(16):1903-13. doi: 10.1001/jama.299.16.1903.
- Background: PubMed 19755303Serruys PW, Ruygrok P, Neuzner J, Piek JJ, Seth A, Schofer JJ, Richardt G, Wiemer M, Carrie D, Thuesen L, Boone E, Miquel-Herbert K, Daemen J. A randomised comparison of an everolimus-eluting coronary stent with a paclitaxel-eluting coronary stent:the SPIRIT II trial. EuroIntervention. 2006 Nov;2(3):286-94.
- Background: PubMed 19758915Tsuchida K, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher AM, Grube E, Haase J, Thuesen L, Hamm CW, Veldhof S, Dorange C, Serruys PW. One-year results of a durable polymer everolimus-eluting stent in de novo coronary narrowings (The SPIRIT FIRST Trial). EuroIntervention. 2005 Nov;1(3):266-72.
- Background: PubMed 19758878Serruys PW, Ong AT, Piek JJ, Neumann FJ, van der Giessen WJ, Wiemer M, Zeiher A, Grube E, Haase J, Thuesen L, Hamm C, Otto-Terlouw PC. A randomized comparison of a durable polymer Everolimus-eluting stent with a bare metal coronary stent: The SPIRIT first trial. EuroIntervention. 2005 May;1(1):58-65.
- Background: PubMed 11177716Tsuji T, Tamai H, Igaki K, Kyo E, Kosuga K, Hata T, Okada M, Nakamura T, Komori H, Motohara S, Uehata H. Biodegradable Polymeric Stents. Curr Interv Cardiol Rep. 2001 Feb;3(1):10-17.
- Background: PubMed 18342684Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8.
- Background: PubMed 19758877Grube E, Hauptmann KE, Buellesfeld L, Lim V, Abizaid A. Six-month results of a randomized study to evaluate safety and efficacy of a Biolimus A9 eluting stent with a biodegradable polymer coating. EuroIntervention. 2005 May;1(1):53-7.
- Individual participant dataSharing planned: Undecided. The sponsor has exclusive ownership of the trial data and results. During the clinical trial process, the sponsor has the right to consult and use all the data and results obtained from the trial. Before the results of each site are published and/or reported, any single clinical trial site is not allowed to publish and/or report its results. The sponsor agrees that the principal investigator of the trial may publish the results of the clinical trial.
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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.
Wei Yang principal investigator
The Fourth Affiliated Hospital of Harbin Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In-Stent Stenosis (Restenosis) of Coronary Artery Stent and Native Coronary Artery Stenosis, run by Biotronik (Beijing) Medical Device Ltd. at 2 sites in China.
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 3 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: stopped early, as of the sponsor's last update on 16 Dec 2024. 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 China. 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 was stopped early (reason given: According to the renewal registration certificate requirements issued by the NMPA, this product does not need to collect post-market safety data.). 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?
Target lesion failure (TLF) at 1 years ± 60 days after surgery (time frame: 1 years ± 60 days after surgery). 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 NCT05667285, which also lists 36 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 16 Dec 2024.