Stable AnginaNCT02456402
Drug Coated Balloon Compared to Bare Metal Stent for de Novo Coronary Artery Lesions
A study testing Drug Coated Balloon and Bare Metal Stent in people with Stable Angina and Unstable Angina, run by Ulsan University Hospital at 1 site in South Korea.
Trial summary
This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery lesions in patients unable to tolerate dual antiplatelet therapy and at high risk of bleeding. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stable Angina, Unstable Angina
- What is being tested?
- Drug Coated Balloon and Bare Metal Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2015to Oct 2016
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable Angina and Unstable angina
- single de novo coronary artery lesions in a single vessel with > 50% diameter stenosis with a reference diameter > 2.75mm
- Patients at high risk of bleeding and whom cannot tolerate dual antiplatelet therapy for > 1 month are inclusion criteria for the study and are listed here:
- Unexplained anemia
- Atrial fibrillation with CHADSVASC > or equal to 1
- Patients awaiting for non cardiac surgery within a year
Show all 10Show fewer
- History of massive hemorrhage requiring transfusion
- History of upper GI bleeding
- Malignancy
- Poor compliance with medication
Who cannot join
- STEMI/NSTEMI within the preceding 72 hours
- Multivessel disease, chronic total occlusion, long lesions and left main disease
- heart failure with ejection fraction < 35% and/or cardiogenic shock
- Previous history of or planned coronary artery bypass grafting
- life expectancy of less than 1 year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Drug Coated Balloon Compared to Bare Metal Stent Using FFR-guidance for the Treatment of de Novo Coronary Artery Lesions
This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery lesions in patients unable to tolerate dual antiplatelet therapy and at high risk of bleeding. Patients will be randomized after balloon angioplasty to receive either DCB or BMS. Endpoints are late luminal loss at 9 months, and major adverse cardiac events including arterial thrombosis at 1, 9 and 12 months.
Read the detailed description
Although the use of drug-eluting stents (DES) has reduced in-stent restenosis when compared to bare metal stents (BMS) and decreased the incidence of adverse clinical events (1-2), DES therapy is limited by delayed arterial healing, late acquired malapposition and neo-atherosclerosis leading to an increased risk of late stent thrombosis and late restenosis (3-4). Conceptually, a permanent stent inhibits advantageous vascular remodeling and durable polymer provokes excessive inflammation (5). Non-stent based local drug delivery using paclitaxel-coated balloon has emerged as a new clinical treatment alternative by maintaining the anti-proliferative properties of DES (6). There is limited data on the efficacy of Drug Coated Balloon (DCB) treatment for de novo coronary lesions when compared to BMS. To avoid the risk of abrupt closure of target lesion after balloon angioplasty, a reliable predictor of coronary flow is necessary especially in de novo lesions of major coronary arteries. Therefore, using fractional flow reserve (FFR) after angioplasty as a good indicator of immediate functional improvement and reduced restenosis (7), the aim of this study is to assess the efficacy of DCB treatment compared to BMS in patients with de novo coronary artery lesions.
Patients with de novo coronary artery lesions with > 50% stenosis in a single vessel and at high risk of bleeding with the inability to tolerate dual antiplatelet therapy (DAPT) will be included in this trial. Patients will undergo balloon angioplasty and if the FFR post balloon angioplasty is > 0.80, they will be randomized to receive either DCB or BMS. Patients will receive Quantitative Coronary Angiography (QCA) analysis at 9 months follow-up. Endpoints are late luminal loss at 9 months and major adverse events including arterial thrombosis at 1, 9 and 12 months and these endpoints will be compared between DCB and BMS groups.
- Conditions
- Stable Angina, Unstable Angina
- Being tested
- Drug Coated Balloon, Bare Metal Stent
- Medical subject headings
- Angina, Stable, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Coated BalloonDevice
If post balloon angioplasty FFR is more than 0.80, either DCB treatment or BMS implantation will be carried out based on randomization of 1:1. DCB (SeQuent Please paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany) will be applied at the predilated lesions. PCB will be delivered rapidly and inflated for 60 seconds with nominal pressure.
Bare Metal StentDevice
BMS (Vision®) will be applied at the predilated lesions after angiographic confirmation of the target lesion.
| Study group | Role | What they receive |
|---|---|---|
| Drug Coated Balloon | Experimental | PCB (SeQuent Please®, paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany) Receives: Device: Drug Coated Balloon |
| Bare Metal Stent | Active comparator | BMS (Vision®) Receives: Device: Bare Metal Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late luminal loss
Measured: 9 months
Secondary outcomes (3)
Major adverse cardiovascular events (MACE) (death, myocardial infarction, repeat revascularization, recurrent ischemic symptoms)
Measured: Post procedure (up to 1 hour), 1 month, 9 months and 12 months
Arterial thrombosis
Any stent thrombosis - acute, subacute/late stent thrombosis
Measured: Post procedure (up to 1 hour), 1 month, 9 months and 12 months
Fractional Flow Reserve
FFR is the ratio of the pressure measured at the distal portion of the target lesion and the aortic ostium at maximal hyperemia
Measured: Post procedure (up to 1 hour) and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stable AnginaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital
- Responsible party
- Principal investigator, Prof Eun-Seok Shin, MD. PhD., Ulsan University Hospital
- Investigators
- Eun-Seok Shin, M.D., PhD., Principal investigator, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456402
- Sponsor's protocol ID
- 1111
- Status last verified
- Apr 2019
- First submitted
- 18 May 2015
- Last updated
- 3 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
PubMed 12050336Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.
PubMed 14523139Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.
PubMed 16814667Nakazawa G, Vorpahl M, Finn AV, Narula J, Virmani R. One step forward and two steps back with drug-eluting-stents: from preventing restenosis to causing late thrombosis and nouveau atherosclerosis. JACC Cardiovasc Imaging. 2009 May;2(5):625-8. doi: 10.1016/j.jcmg.2009.01.011. No abstract available.
PubMed 19442951Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months? EuroIntervention. 2013 Sep;9(5):620-8. doi: 10.4244/EIJV9I5A99.
PubMed 24058078Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.
PubMed 15302790Bech GJ, Pijls NH, De Bruyne B, Peels KH, Michels HR, Bonnier HJ, Koolen JJ. Usefulness of fractional flow reserve to predict clinical outcome after balloon angioplasty. Circulation. 1999 Feb 23;99(7):883-8. doi: 10.1161/01.cir.99.7.883.
PubMed 10027810Shin ES, Lee JM, Her AY, Chung JH, Eun Lee K, Garg S, Nam CW, Doh JH, Koo BK. Prospective randomized trial of paclitaxel-coated balloon versus bare-metal stent in high bleeding risk patients with de novo coronary artery lesions. Coron Artery Dis. 2019 Sep;30(6):425-431. doi: 10.1097/MCA.0000000000000755.
PubMed 31009399
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Drug Coated Balloon Compared to Bare Metal Stent Using FFR-guidance for the Treatment of de Novo Coronary Artery Lesions
- ClinicalTrials.gov ID
- NCT02456402
- Acronym / sponsor ID
- 1111
- Conditions
- Stable Angina, Unstable Angina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Hospital
- Study start
- Apr 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 28 May 2015 (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.
This randomized trial will assess the efficacy of Drug Coated Balloon (DCB) compared to Bare Metal Stent (BMS) using Fractional Flow Reserve (FFR) guidance for de novo coronary artery lesions in patients unable to tolerate dual antiplatelet therapy and at high risk of bleeding. Patients will be randomized after balloon angioplasty to receive either DCB or BMS. Endpoints are late luminal loss at 9 months, and major adverse cardiac events including arterial thrombosis at 1, 9 and 12 months.
Detailed description
Although the use of drug-eluting stents (DES) has reduced in-stent restenosis when compared to bare metal stents (BMS) and decreased the incidence of adverse clinical events (1-2), DES therapy is limited by delayed arterial healing, late acquired malapposition and neo-atherosclerosis leading to an increased risk of late stent thrombosis and late restenosis (3-4). Conceptually, a permanent stent inhibits advantageous vascular remodeling and durable polymer provokes excessive inflammation (5). Non-stent based local drug delivery using paclitaxel-coated balloon has emerged as a new clinical treatment alternative by maintaining the anti-proliferative properties of DES (6). There is limited data on the efficacy of Drug Coated Balloon (DCB) treatment for de novo coronary lesions when compared to BMS. To avoid the risk of abrupt closure of target lesion after balloon angioplasty, a reliable predictor of coronary flow is necessary especially in de novo lesions of major coronary arteries. Therefore, using fractional flow reserve (FFR) after angioplasty as a good indicator of immediate functional improvement and reduced restenosis (7), the aim of this study is to assess the efficacy of DCB treatment compared to BMS in patients with de novo coronary artery lesions.
Patients with de novo coronary artery lesions with > 50% stenosis in a single vessel and at high risk of bleeding with the inability to tolerate dual antiplatelet therapy (DAPT) will be included in this trial. Patients will undergo balloon angioplasty and if the FFR post balloon angioplasty is > 0.80, they will be randomized to receive either DCB or BMS. Patients will receive Quantitative Coronary Angiography (QCA) analysis at 9 months follow-up. Endpoints are late luminal loss at 9 months and major adverse events including arterial thrombosis at 1, 9 and 12 months and these endpoints will be compared between DCB and BMS groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Coated Balloon | Experimental | Device: Drug Coated BalloonPCB (SeQuent Please®, paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany) |
| Bare Metal Stent | Active comparator | Device: Bare Metal StentBMS (Vision®) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Stable Angina and Unstable angina
- single de novo coronary artery lesions in a single vessel with > 50% diameter stenosis with a reference diameter > 2.75mm
- Patients at high risk of bleeding and whom cannot tolerate dual antiplatelet therapy for > 1 month are inclusion criteria for the study and are listed here:
- Unexplained anemia
- Atrial fibrillation with CHADSVASC > or equal to 1
Key exclusion criteria (5 listed)
- STEMI/NSTEMI within the preceding 72 hours
- Multivessel disease, chronic total occlusion, long lesions and left main disease
- heart failure with ejection fraction < 35% and/or cardiogenic shock
- Previous history of or planned coronary artery bypass grafting
- life expectancy of less than 1 year
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 |
|---|---|---|
| Drug Coated BalloonIf post balloon angioplasty FFR is more than 0.80, either DCB treatment or BMS implantation will be carried out based on randomization of 1:1. DCB (SeQuent Please paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany) will be applied at the predilated lesions. PCB will be delivered rapidly and inflated for 60 seconds with nominal pressure. | Device | Drug Coated Balloon |
| Bare Metal StentBMS (Vision®) will be applied at the predilated lesions after angiographic confirmation of the target lesion. | Device | Bare Metal Stent |
Primary outcome
Late luminal loss
Time frame: 9 months
3 secondary outcomes
Major adverse cardiovascular events (MACE) (death, myocardial infarction, repeat revascularization, recurrent ischemic symptoms)
Time frame: Post procedure (up to 1 hour), 1 month, 9 months and 12 months
Arterial thrombosis
Time frame: Post procedure (up to 1 hour), 1 month, 9 months and 12 months
Fractional Flow Reserve
Time frame: Post procedure (up to 1 hour) and 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 3 Apr 2019.
- Background: PubMed 12050336Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
- Background: PubMed 14523139Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE; SIRIUS Investigators. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003 Oct 2;349(14):1315-23. doi: 10.1056/NEJMoa035071.
- Background: PubMed 16814667Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.
- Background: PubMed 19442951Nakazawa G, Vorpahl M, Finn AV, Narula J, Virmani R. One step forward and two steps back with drug-eluting-stents: from preventing restenosis to causing late thrombosis and nouveau atherosclerosis. JACC Cardiovasc Imaging. 2009 May;2(5):625-8. doi: 10.1016/j.jcmg.2009.01.011. No abstract available.
- Background: PubMed 24058078Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months? EuroIntervention. 2013 Sep;9(5):620-8. doi: 10.4244/EIJV9I5A99.
- Background: PubMed 15302790Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.
- Background: PubMed 10027810Bech GJ, Pijls NH, De Bruyne B, Peels KH, Michels HR, Bonnier HJ, Koolen JJ. Usefulness of fractional flow reserve to predict clinical outcome after balloon angioplasty. Circulation. 1999 Feb 23;99(7):883-8. doi: 10.1161/01.cir.99.7.883.
- Derived from this study: PubMed 31009399Shin ES, Lee JM, Her AY, Chung JH, Eun Lee K, Garg S, Nam CW, Doh JH, Koo BK. Prospective randomized trial of paclitaxel-coated balloon versus bare-metal stent in high bleeding risk patients with de novo coronary artery lesions. Coron Artery Dis. 2019 Sep;30(6):425-431. doi: 10.1097/MCA.0000000000000755.
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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.
Eun-Seok Shin, M.D., PhD. principal investigator
Ulsan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug Coated Balloon and Bare Metal Stent in people with Stable Angina and Unstable Angina, run by Ulsan University Hospital at 1 site in South Korea.
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 5 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 3 Apr 2019. 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 South Korea. 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?
Late luminal loss (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 NCT02456402, which also lists 8 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 3 Apr 2019.