DES In-stent StenosisFIMLIMUSDCBNCT02996318
Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
A study testing Paclitaxel coated balloon (SeQuent Please) and Sirolimus coated balloon in people with DES In-stent Stenosis, run by InnoRa GmbH at 5 sites in Malaysia.
Trial summary
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DES In-stent Stenosis
- What is being tested?
- Paclitaxel coated balloon (SeQuent Please) and Sirolimus coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesMalaysia
- Study dates
- 1 Dec 2015to 1 Dec 2017
- 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
- 18 years of age
- Clinical evidence of stable or unstable angina (acute coronary syndrome) or a positive functional study
- Patients with ≤ 2 primary drug-eluting stent in-stent restenosis (DES-ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥ 50% and positive functional study) including margin stenosis with max 5mm distance to the stent.
Who cannot join
- Chronic renal insufficiency with serum creatinine levels > 2.0 mg per deciliter
- Known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or sirolimus, and sensitivity to contrast media not amenable to premedication
- Concomitant medical illness associated with a life-expectancy of less than two year
- Lesion length (ISR) > 35 mm, vessel diameter < 2.5 mm
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Malaysia5 sites
Queen Elizabeth Hospital II
Kota Kinabalu, 88300
National Heart Institute
Kuala Lumpur, 50400
University Malaya
Kuala Lumpur, 50603
Sarawak Genaral Hospital Heart Centre
Kuching, 94300
Hospital Pulau Pinang
Pulau Pinang, 10990
About this study
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.
Read the detailed description
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.
Patient population will consist of male and female adults suffering from coronary drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to the inclusion and exclusion criteria as defined below.
In Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA).
The study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in 50 patients.
- Conditions
- DES In-stent Stenosis
- Being tested
- Paclitaxel coated balloon (SeQuent Please), Sirolimus coated balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel coated balloon (SeQuent Please)Device
Paclitaxel coated balloon (SeQuent Please)
Sirolimus coated balloonDevice
Sirolimus coated balloon
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus coated Balloon | Experimental | treatment of coronary DES-ISR with a sirolimus coated balloon Receives: Device: Sirolimus coated balloon |
| Paclitaxel coated balloon (SeQuent Please) | Active comparator | treatment of coronary DES-ISR with a paclitaxel coated balloon Receives: Device: Paclitaxel coated balloon (SeQuent Please) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late lumen loss
Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI
Measured: 6 months
Secondary outcomes (2)
Procedural Success
≤ 30% final stenosis, TIMI III flow, no flow-limiting dissection at the conclusion of the procedure, and the absence of in-hospital (24 hour after treatment) MACE
Measured: 24 hours
MACE (Major adverse cardiac events)
MACE will be defined as the occurrence of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization at 6 months and 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start1 Dec 2015
- Primary completion1 Aug 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DES In-stent StenosisStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnoRa GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996318
- Sponsor's protocol ID
- SI01
- Acronym
- FIMLIMUSDCB
- Status last verified
- Aug 2021
- First submitted
- 9 Dec 2016
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Scheller B, Mangner N, Abdul Kader MASK, Wan Ahmad WA, Jeger R, Wohrle J, Ong TK, Liew HB, Gori T, Mahfoud F, Nuruddin AA, Woitek F, Abidin IZ, Schwenke C, Schnorr B, Mohd Ali R. Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions. Circ Cardiovasc Interv. 2022 Sep;15(9):e012305. doi: 10.1161/CIRCINTERVENTIONS.122.012305. Epub 2022 Sep 20.
PubMed 36126132Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.
PubMed 30898253
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Coronary In-Stent Restenosis by a Sirolimus (Rapamycin) Coated Balloon or a Paclitaxel Coated Balloon
- ClinicalTrials.gov ID
- NCT02996318
- Acronym / sponsor ID
- FIMLIMUSDCB / SI01
- Conditions
- DES In-stent Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- InnoRa GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 19 Dec 2016 (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 aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.
Detailed description
The aim of the study is to investigate the non-inferiority of the new sirolimus-coated balloon catheters in comparison to the paclitaxel-coated SQP with regard to acute tolerance, safety and efficacy in coronary DES in-stent restenosis.
Patient population will consist of male and female adults suffering from coronary drug-eluting stent (DES) restenosis, which is to be treated by a study balloon according to the inclusion and exclusion criteria as defined below.
In Late lumen loss lesion (difference between the angiographic in-lesion MLD post procedural and at 6 months follow-up) will be evaluated by quantitative coronary angiography (QCA).
The study will be performed as a single-blind, SQP controlled study in 4 - 6 study centers in 50 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus coated Balloon | Experimental | Device: Sirolimus coated balloontreatment of coronary DES-ISR with a sirolimus coated balloon |
| Paclitaxel coated balloon (SeQuent Please) | Active comparator | Device: Paclitaxel coated balloon (SeQuent Please)treatment of coronary DES-ISR with a paclitaxel coated balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age
- Clinical evidence of stable or unstable angina (acute coronary syndrome) or a positive functional study
- Patients with ≤ 2 primary drug-eluting stent in-stent restenosis (DES-ISR) lesions (≥ 70% diameter stenosis by visual estimation or ≥ 50% and positive functional study) including margin stenosis with max 5mm distance to the stent.
Key exclusion criteria (4 listed)
- Chronic renal insufficiency with serum creatinine levels > 2.0 mg per deciliter
- Known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or sirolimus, and sensitivity to contrast media not amenable to premedication
- Concomitant medical illness associated with a life-expectancy of less than two year
- Lesion length (ISR) > 35 mm, vessel diameter < 2.5 mm
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 |
|---|---|---|
| Paclitaxel coated balloon (SeQuent Please)Paclitaxel coated balloon (SeQuent Please) | Device | Paclitaxel coated balloon (SeQuent Please) |
| Sirolimus coated balloonSirolimus coated balloon | Device | Sirolimus coated Balloon |
Primary outcome
Late lumen loss
Time frame: 6 months
Difference between minimal lumen diameter at follow-up coronary angiography and baseline after PCI
2 secondary outcomes
Procedural Success
Time frame: 24 hours
MACE (Major adverse cardiac events)
Time frame: 12 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 27 Aug 2021.
- Derived from this study: PubMed 36126132Scheller B, Mangner N, Abdul Kader MASK, Wan Ahmad WA, Jeger R, Wohrle J, Ong TK, Liew HB, Gori T, Mahfoud F, Nuruddin AA, Woitek F, Abidin IZ, Schwenke C, Schnorr B, Mohd Ali R. Combined Analysis of Two Parallel Randomized Trials of Sirolimus-Coated and Paclitaxel-Coated Balloons in Coronary In-Stent Restenosis Lesions. Circ Cardiovasc Interv. 2022 Sep;15(9):e012305. doi: 10.1161/CIRCINTERVENTIONS.122.012305. Epub 2022 Sep 20.
- Derived from this study: PubMed 30898253Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.
- Individual participant dataSharing planned: No
Related trials for DES In-stent Stenosis
Active, not recruiting
STrategies of Scheduled Drug-coated Balloons (DCB) Versus Conventional DES for the interveNTional Therapy of de Novo Lesions in Large Coronary vESSels (STENTLESS) Trial
Drug-coated Balloon, Drug-eluting Stent
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel coated balloon (SeQuent Please) and Sirolimus coated balloon in people with DES In-stent Stenosis, run by InnoRa GmbH at 5 sites in Malaysia.
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 4 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 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Malaysia. 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 lumen loss (time frame: 6 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 NCT02996318, which also lists 2 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 27 Aug 2021.