Coronary Artery DiseaseNCT01166711
Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent
A study testing Coroflex Blue (BMS) followed by SeQuent Please (DEB) and Coroflex Please (DES) in people with Coronary Artery Disease, run by Aesculap AG at 1 site in Poland.
Trial summary
The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coroflex Blue (BMS) followed by SeQuent Please (DEB) and Coroflex Please (DES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 sitePoland
- Study dates
- Aug 2010to Jul 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina and silent ischemia
- Presence of one or more coronary artery stenosis >50% in a native coronary artery from 2.25 to 3.5 mm in diameter that can be covered with one stent
- One lesion treated with the study device
Who cannot join
- Pregnancy
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, paclitaxel, cobalt, chromium or contrast material
- Inability to provide informed consent
- Currently participating in another trial before reaching the primary endpoint
- Elective surgery within 12 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri-surgical period
- Acute or recent myocardial infarction
Show all 11Show fewer
- left ventricular ejection fraction (LVEF) < 30 %
- Stroke or transient ischemic attack within 6 months
- Stented segment longer than 23 mm
- Vessel diameter of less than 2,5 mm
- Significant calcification, chronic total occlusion (CTO) or thrombus in the target lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SeQuent 1000 - Treatment of Coronary Artery Disease With Bare Metal Stent Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent: Randomized Trial
The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.
- Conditions
- Coronary Artery Disease
- Being tested
- Coroflex Blue (BMS) followed by SeQuent Please (DEB), Coroflex Please (DES)
- 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.
Coroflex Blue (BMS) followed by SeQuent Please (DEB)Device
Also called Coroflex Blue, Cobalt Chromium stent, BMS, SeQuent Please
- standard techniques will be used
- maximal vasodilatation after nitro application
- baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap)
- 6 French guiding catheter at least
- target lesion will be crossed with standard guidewire
- direct stenting at the discretion of the investigator
- if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted)
- full lesion coverage will be ensured (with one or more stents)
- only insert assigned stent type
- BMS needs to be fully embedded in vessel wall
- post-dilation with high pressure is required before treatment with DEB
- DEB will be inflated with nominal pressure (balloon equates to vessel diameter)
- length of DEB should exceed the BMS by 2-3 mm on each side
- if dissection, full length of dissection and optional additional stented area should be treated with additional DEB (to avoid geographic miss)
Coroflex Please (DES)Device
Also called Coroflex Please, Paclitaxel-Eluting Stent, DES
- standard techniques will be used
- maximal vasodilatation after nitro application
- baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap)
- 6 French guiding catheter at least
- target lesion will be crossed with standard guidewire
- direct stenting at the discretion of the investigator
- if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted)
- full lesion coverage will be ensured (with one or more stents)
- only insert assigned stent type
| Study group | Role | What they receive |
|---|---|---|
| Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB) | Experimental | Not described Receives: Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB) |
| Drug Eluting Stent (DES) | Active comparator | Not described Receives: Device: Coroflex Please (DES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACE) - target vessel failure (TVF)
consisting of the composite of cardiac death, myocardial infarction (Q-wave and Non-Q wave) localized at the territory supplied by the treated vessel or target vessel revascularization (TVR) by either percutaneous coronary intervention or bypass graft surgery in the overall population
Measured: 9 months
Secondary outcomes (11)
Major adverse cardiac events (MACE)
defined as the composite of cardiovascular death, stroke, myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR), as well as the individual components of target vessel revascularization (TVR) and Major adverse cardiac events (MACE) and stent thrombosis
Measured: 1 year
in-stent binary restenosis
defined as >= 50 % diameter stenosis (% DS)
Measured: 9 months
Angiographic and clinical stent thrombosis
Measured: 30 days
Angiographic and clinical stent thrombosis
Measured: 6 months
Angiographic and clinical stent thrombosis
Measured: 9 months
Angiographic and clinical stent thrombosis
Measured: 1 year
Angiographic and clinical stent thrombosis
Measured: 2 years
Angiographic and clinical stent thrombosis
Measured: 3 years
In-stent and in-segment minimal luminal diameter (MLD)
Measured: 9 months
In-segment percent diameter stenosis (%DS)
Measured: 9 months
In-stent and in-segment late luminal loss
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2013
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paweł E. Buszman, MD, PhD, Principal investigator, American Heart of Poland, Katowice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166711
- Sponsor's protocol ID
- SEQUENT 1000
- Status last verified
- Jan 2018
- First submitted
- 20 Jul 2010
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zurakowski A, Buszman PP, Milewski KP, Janas A, Gorycki B, Kondys M, Gasior P, Michalak M, Boxberger M, Peppas A, Granada JF, Buszman PE. Stenting and Adjunctive Delivery of Paclitaxel Via Balloon Coating Versus Durable Polymeric Matrix for De Novo Coronary Lesions: Clinical and Angiographic Results from the Prospective Randomized Trial. J Interv Cardiol. 2015 Aug;28(4):348-57. doi: 10.1111/joic.12210.
PubMed 26224390
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SeQuent 1000 - Treatment of Coronary Artery Disease With Bare Metal Stent Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent: Randomized Trial
- ClinicalTrials.gov ID
- NCT01166711
- Acronym / sponsor ID
- SEQUENT 1000
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 21 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.
The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB) | Experimental | Device: Coroflex Blue (BMS) followed by SeQuent Please (DEB) |
| Drug Eluting Stent (DES) | Active comparator | Device: Coroflex Please (DES) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina and silent ischemia
- Presence of one or more coronary artery stenosis >50% in a native coronary artery from 2.25 to 3.5 mm in diameter that can be covered with one stent
- One lesion treated with the study device
Key exclusion criteria (11 listed)
- Pregnancy
- Known intolerance to aspirin, clopidogrel, heparin, stainless steel, paclitaxel, cobalt, chromium or contrast material
- Inability to provide informed consent
- Currently participating in another trial before reaching the primary endpoint
- Elective surgery within 12 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri-surgical period
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 |
|---|---|---|
| Coroflex Blue (BMS) followed by SeQuent Please (DEB)Also: Coroflex Blue, Cobalt Chromium stent, BMS, SeQuent Please* standard techniques will be used * maximal vasodilatation after nitro application * baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap) * 6 French guiding catheter at least * target lesion will be crossed with standard guidewire * direct stenting at the discretion of the investigator * if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted) * full lesion coverage will be ensured (with one or more stents) * only insert assigned stent type * BMS needs to be fully embedded in vessel wall * post-dilation with high pressure is required before treatment with DEB * DEB will be inflated with nominal pressure (balloon equates to vessel diameter) * length of DEB should exceed the BMS by 2-3 mm on each side * if dissection, full length of dissection and optional additional stented area should be treated with additional DEB (to avoid geographic miss) | Device | Bare Metal Stent (BMS) followed by Drug Eluting Balloon (DEB) |
| Coroflex Please (DES)Also: Coroflex Please, Paclitaxel-Eluting Stent, DES* standard techniques will be used * maximal vasodilatation after nitro application * baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap) * 6 French guiding catheter at least * target lesion will be crossed with standard guidewire * direct stenting at the discretion of the investigator * if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted) * full lesion coverage will be ensured (with one or more stents) * only insert assigned stent type | Device | Drug Eluting Stent (DES) |
Primary outcome
Major adverse cardiac events (MACE) - target vessel failure (TVF)
Time frame: 9 months
consisting of the composite of cardiac death, myocardial infarction (Q-wave and Non-Q wave) localized at the territory supplied by the treated vessel or target vessel revascularization (TVR) by either percutaneous coronary intervention or bypass graft surgery in the overall population
11 secondary outcomes
Major adverse cardiac events (MACE)
Time frame: 1 year
in-stent binary restenosis
Time frame: 9 months
Angiographic and clinical stent thrombosis
Time frame: 30 days
Angiographic and clinical stent thrombosis
Time frame: 6 months
Angiographic and clinical stent thrombosis
Time frame: 9 months
Angiographic and clinical stent thrombosis
Time frame: 1 year
Angiographic and clinical stent thrombosis
Time frame: 2 years
Angiographic and clinical stent thrombosis
Time frame: 3 years
In-stent and in-segment minimal luminal diameter (MLD)
Time frame: 9 months
In-segment percent diameter stenosis (%DS)
Time frame: 9 months
In-stent and in-segment late luminal loss
Time frame: 9 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 10 Jan 2018.
- Results publication: PubMed 26224390Zurakowski A, Buszman PP, Milewski KP, Janas A, Gorycki B, Kondys M, Gasior P, Michalak M, Boxberger M, Peppas A, Granada JF, Buszman PE. Stenting and Adjunctive Delivery of Paclitaxel Via Balloon Coating Versus Durable Polymeric Matrix for De Novo Coronary Lesions: Clinical and Angiographic Results from the Prospective Randomized Trial. J Interv Cardiol. 2015 Aug;28(4):348-57. doi: 10.1111/joic.12210.
- Individual participant dataSharing planned: No
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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.
Paweł E. Buszman, MD, PhD principal investigator
American Heart of Poland, Katowice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coroflex Blue (BMS) followed by SeQuent Please (DEB) and Coroflex Please (DES) in people with Coronary Artery Disease, run by Aesculap AG at 1 site in Poland.
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 11 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 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Major adverse cardiac events (MACE) - target vessel failure (TVF) (time frame: 9 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 NCT01166711, which also lists 1 linked publication.
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 10 Jan 2018.