Ischemic Heart DiseasePhase 4SINGLEKISSNCT00798954
Treatment of Bifurcation Lesions by SINGLE STENT and KISSing Balloon Trial
A Phase 4 study testing Sirolimus-eluting coronary stent (Cypher) and Paclitaxel-eluting stent (TAXUS) in people with Ischemic Heart Disease and Restenosis, run by Vulnerable Plaque Society at 17 sites in Japan.
Trial summary
The use of DES have not diminished the need of improved treatment strategies , especially the treatment of bifurcation lesions still leave much to be clarified. Particularly, for bifurcation lesions where stenting the main branch could result in an obstruction of a vital side branch, many reports have been about using… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Heart Disease, Restenosis
- What is being tested?
- Sirolimus-eluting coronary stent (Cypher) and Paclitaxel-eluting stent (TAXUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 17 sitesJapan
- Study dates
- Jun 2007to Mar 2010
- Phase
- Phase 4
- 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
- Patient Inclusion Criteria:
- Age ≥18 to <81 years and are able to undergo CABG
- Females who are not pregnant
- Patients who present with angina symptoms or myocardial ischemia
- Patients available for post-procedural observation and coronary angiography at 9 months
- Patients who have signed patient informed consent
Show all 13Show fewer
- Angiographic Inclusion Criteria:
- Bifurcation lesion with ≥2.0mm side branch diameter as confirmed angiographically (the Duke Classification (see Reference 1)
- The target lesion without remote lesions in the same vessel.
- De novo lesion or non-stented restenosed lesion
- Lesion which is eligible for stent implantation
- Main branch reference vessel diameter of ≥2.5 mm by visual assessment
- If two or more bifurcated lesions are present in the reference lesion, the proximal lesion shall be included in this study.
Who cannot join
- Patient Exclusion Criteria:
- Patients contraindicated for antiplatelet therapy or anticoagulant therapy
- Patients with significant allergic reaction to contrast medium
- Patients who are pregnant or may be pregnant
- Patients with left ventricle ejection fraction of <30%
- Patients deemed inappropriate by physician
Show all 13Show fewer
- Angiographic Exclusion Criteria:
- Main branch reference vessel diameter of ≥4.5 mm by angiography
- Bypass grafts lesions
- In-stent restenosis lesions
- Highly tortuous lesions of ≥60 degrees
- Highly calcified lesions in which full stent dilatation may not be possible
- The target lesion with remote lesions in the same vessel.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
Kihara Junkanki Hospital
Asahikawa, Hokkaido
Chitose City Hospital
Chitose, Hokkaido, 0668550
Tokyo Metropolitan Police Hospital
Chiyoda City, Tokyo, 1028161
Teikyo University Chiba Medical Center
Ichihara, Chiba, 2990111
Rinku General Medical Center
Izumisano, Osaka, 5980048
Shinko Kagogwa Hospital
Kakogawa, Hyōgo, 6750115
Southen Tohoku Research Institute
Kōriyama, Fukushima, 9638563
Gunma Cardiovascular Center
Maebashi, Gunma, 3710004
Matsubara Tokushukai Hospital
Matsubara, Osaka, 5800032
Cardiovascular Institute Hospital
Minatoku, Tokyou, 1060032
Sanda City Hospital
Sanda, Hyōgo, 6691321
Hokkaido University Hospital
Sapporo, Hokkaido, 0608648
Tokyo Medical University Hospital
Shinjuku, Tokyo, 1600023
Itabashi Chuo Medical Center
tabashi City, Tokyo, 1740051
Higashi Cardiovascular Clinic
Toyohashi, Aichi-ken, 4400836
Vulnerable Plaque Society
Toyohashi, Aichi-ken, 4400850
Toyohashi Heart Center
Toyohashi, Aichi-ken, 4418530
About this study
Official title: A Multi-center Trial to Evaluate Paclitaxel- and Sirolimus-eluting Stents in Provisional T-stenting With Kissing Balloon Technique in the Treatment of Bifurcation Lesions
The use of DES have not diminished the need of improved treatment strategies , especially the treatment of bifurcation lesions still leave much to be clarified. Particularly, for bifurcation lesions where stenting the main branch could result in an obstruction of a vital side branch, many reports have been about using 2 drug-eluting stents. Resulting in less than favorable, target lesion revascularization (TLR) rates, with 10-15% for main branch and 11-40% for side branch.
In Japan, the PERFECT multi-center registry evaluated outcomes of single stenting plus kissing balloon technique after Directional Coronary Atherectomy (DCA) removal of tissue plaques. TLR rates for both main branch and side branch were a satisfactory 1.3%. However, the DCA technique is mainly suitable for proximal coronary artery lesions, and takes skilled operators.
Read more
For the treatment of relatively distal bifurcation lesions, where first POBA is performed, then the lesion is stented, followed by kissing balloon technique to fully expand the side branch, is considered a viable treatment. The Toyohashi Heart Center outcomes from August 2004 for this single stent and kissing ballooning technique, using the sirolimus-eluting stent on bifurcation lesions, achieved a satisfactory 5.2% TLR for both main and side branches, suggesting that using two stents may not be necessarily the ideal treatment.
The paclitaxel-eluting stent is expected to become available in Japan from June 2007. This stent's cells can be expanded to a maximum of 3.5mm, which should provide a larger lumen access for side-branch treatment.
As such, we developed this study to compare the outcomes of paclitaxel-eluting and sirolimus-eluting stents in bifurcation lesions that require side branch dilatation using the kissing ballooning technique.
Read the detailed description
- Primary Endpoints Target lesion revascularization after one year
- Secondary Endpoints Secondary endpoints be evaluated in terms of safety and efficacy.
2-1 Safety
- Major complications associated with procedure (death, QMI, CABG)
- Major complications at follow-up (within 9 months) (death, QMI, CABG)
- Target vessel revascularization (TVR) performed within 9 months 2-2 Efficacy
- Acute angiographic success
- Minimum lumen diameter (MLD) ・% stenosis 2. Angiographic success at follow-up
- Minimum lumen diameter (MLD) ・% stenosis
- Loss index
- Late loss
- Conditions
- Ischemic Heart Disease, Restenosis
- Being tested
- Sirolimus-eluting coronary stent (Cypher), Paclitaxel-eluting stent (TAXUS)
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sirolimus-eluting coronary stent (Cypher)Device
Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.
Paclitaxel-eluting stent (TAXUS)Device
Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions.
| Study group | Role | What they receive |
|---|---|---|
| TAXUS | Active comparator | Not described Receives: Device: Paclitaxel-eluting stent (TAXUS) |
| Cypher | Active comparator | Not described Receives: Device: Sirolimus-eluting coronary stent (Cypher) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion revascularization
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study startJun 2007
- Primary completionDec 2008
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vulnerable Plaque Society
- Sponsor type
- Research network
- Investigators
- Kenya Nasu, MD, Principal investigator, Toyohashi Heart CenterYuji Oikawa, MD, Principal investigator, Cardiovascular Institute hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798954
- Sponsor's protocol ID
- SKT
- Acronym
- SINGLEKISS
- Status last verified
- Jun 2010
- First submitted
- 12 Feb 2008
- Last updated
- 10 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Trial to Evaluate Paclitaxel- and Sirolimus-eluting Stents in Provisional T-stenting With Kissing Balloon Technique in the Treatment of Bifurcation Lesions
- ClinicalTrials.gov ID
- NCT00798954
- Acronym / sponsor ID
- SINGLEKISS / SKT
- Conditions
- Ischemic Heart Disease, Restenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Vulnerable Plaque SocietyResearch network
- Study start
- Jun 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Nov 2008 (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 use of DES have not diminished the need of improved treatment strategies , especially the treatment of bifurcation lesions still leave much to be clarified. Particularly, for bifurcation lesions where stenting the main branch could result in an obstruction of a vital side branch, many reports have been about using 2 drug-eluting stents. Resulting in less than favorable, target lesion revascularization (TLR) rates, with 10-15% for main branch and 11-40% for side branch.
In Japan, the PERFECT multi-center registry evaluated outcomes of single stenting plus kissing balloon technique after Directional Coronary Atherectomy (DCA) removal of tissue plaques. TLR rates for both main branch and side branch were a satisfactory 1.3%. However, the DCA technique is mainly suitable for proximal coronary artery lesions, and takes skilled operators.
For the treatment of relatively distal bifurcation lesions, where first POBA is performed, then the lesion is stented, followed by kissing balloon technique to fully expand the side branch, is considered a viable treatment. The Toyohashi Heart Center outcomes from August 2004 for this single stent and kissing ballooning technique, using the sirolimus-eluting stent on bifurcation lesions, achieved a satisfactory 5.2% TLR for both main and side branches, suggesting that using two stents may not be necessarily the ideal treatment.
The paclitaxel-eluting stent is expected to become available in Japan from June 2007. This stent's cells can be expanded to a maximum of 3.5mm, which should provide a larger lumen access for side-branch treatment.
As such, we developed this study to compare the outcomes of paclitaxel-eluting and sirolimus-eluting stents in bifurcation lesions that require side branch dilatation using the kissing ballooning technique.
Detailed description
- Primary Endpoints Target lesion revascularization after one year
- Secondary Endpoints Secondary endpoints be evaluated in terms of safety and efficacy.
2-1 Safety
- Major complications associated with procedure (death, QMI, CABG)
- Major complications at follow-up (within 9 months) (death, QMI, CABG)
- Target vessel revascularization (TVR) performed within 9 months 2-2 Efficacy
- Acute angiographic success
- Minimum lumen diameter (MLD) ・% stenosis 2. Angiographic success at follow-up
- Minimum lumen diameter (MLD) ・% stenosis
- Loss index
- Late loss
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAXUS | Active comparator | Device: Paclitaxel-eluting stent (TAXUS) |
| Cypher | Active comparator | Device: Sirolimus-eluting coronary stent (Cypher) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 to <81 years and are able to undergo CABG
- Females who are not pregnant
- Patients who present with angina symptoms or myocardial ischemia
- Patients available for post-procedural observation and coronary angiography at 9 months
- Patients who have signed patient informed consent
Key exclusion criteria (13 listed)
- Patients contraindicated for antiplatelet therapy or anticoagulant therapy
- Patients with significant allergic reaction to contrast medium
- Patients who are pregnant or may be pregnant
- Patients with left ventricle ejection fraction of <30%
- Patients deemed inappropriate by physician
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 |
|---|---|---|
| Sirolimus-eluting coronary stent (Cypher)Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions. | Device | Cypher |
| Paclitaxel-eluting stent (TAXUS)Drug eluting stents: Comparison Sirolimus with Paclitaxel eluting stents for treatment of coronary bifurcation lesions. | Device | TAXUS |
Primary outcome
Target lesion revascularization
Time frame: one year
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 Jun 2010.
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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.
Kenya Nasu, MD principal investigator
Toyohashi Heart Center
Yuji Oikawa, MD principal investigator
Cardiovascular Institute hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sirolimus-eluting coronary stent (Cypher) and Paclitaxel-eluting stent (TAXUS) in people with Ischemic Heart Disease and Restenosis, run by Vulnerable Plaque Society at 17 sites in Japan.
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 13 inclusion and 13 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 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Japan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion revascularization (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2010.