In-stent RestenosisNCT03529006
Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis
A study testing Sequent Please inflation and Absorb BVS implantation in people with In-stent Restenosis, run by Luzerner Kantonsspital.
Trial summary
The primary objective of this study is to demonstrate superiority of the Absorb scaffold compared to the Sequent Please Drug Coated Balloon when treating patients with In-Stent-Restenosis (ISR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In-stent Restenosis
- What is being tested?
- Sequent Please inflation and Absorb BVS implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jun 2020
- 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
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with ISR requiring percutaneous coronary intervention: visual diameter stenosis > 70 % and/or Fractional Flow Reserve < 0.81 and/or non-invasive testing demonstrating ischemia. This real-life population with in-stent restenosis beside typical stable patients with ISR includes ACS patients with thrombus containing lesions, patients with multivessel disease, patients with ISR in non-infarct related artery, with ISR in BMS (bare metal stent), DES (drug eluting stent) or BVS, ISR in lesion previously treated by POBA (plain old balloon angioplasty), DEB or additional stent implantation.
- Double anti-platelet therapy for the duration of at least 12 months is considered possible at the time of intervention.
Who cannot join
- Difficulty with deliver and implant the Absorb scaffold (e.g. highly calcified lesions).
- Patients who have any contraindications for using DEB (SeQent Please) or BVS (Absorb).
About this study
The primary objective of this study is to demonstrate superiority of the Absorb scaffold compared to the Sequent Please Drug Coated Balloon when treating patients with In-Stent-Restenosis (ISR).
Read the detailed description
Absorb ISR is randomized-controlled trial of Absorb scaffold vs. Sequent Please drug coated balloon in an all-comers population with in-stent-restenosis. The patients will be randomized in a 1:1 fashion and the investigators intend to include 150 patients.
Repeat coronary angiography will be performed 9 months post intervention in all subjects. Optical coherence tomography will be performed at baseline and at 9 months in both groups.
All patients presenting with ISR and requiring percutaneous coronary intervention will be eligible to be included in this study. This will include patients with stable angina and those presenting with acute coronary syndrome (ACS).
- Conditions
- In-stent Restenosis
- Being tested
- Sequent Please inflation, Absorb BVS implantation
- Keywords
- bioresorbable vascular scaffold, drug eluting balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sequent Please inflationProcedure or surgery
PCI procedure for treatment of ISR with DEB - Sequent Please - inflation
Absorb BVS implantationProcedure or surgery
PCI procedure for treatment of ISR with Absorb BVS implantation
| Study group | Role | What they receive |
|---|---|---|
| Sequent Please Drug Coated Balloon Group | Active comparator | For Sequent Please Group, PCI (percutaneous coronary intervention) PCI procedure with Sequent Please inflation will be performed - drug eluting balloon will be used in the narrowed part of the artery. This method of treatment is one of the standard ones, which is typically used for treatment patients with diagnosis of in stent restenosis, the exact intervention and anesthesia procedures will be performed according to physician's usual practice. For bailout situation Xience stent implantation is possible. Receives: Procedure: Sequent Please inflation |
| Absorb Stent Group | Active comparator | Absorb scaffold group will be treated by PCI procedure with Absorb BVS implantation - implantation of bioresorbable vascular scaffold (Absorb). Coronary stent implantation for treatment in stent restenosis is one of the standard method of treatment this disease, but Absorb system has not been investigated in this indication yet. Receives: Procedure: Absorb BVS implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic late lumen loss at 9 months
Late lumen loss will be calculated based on index and control coronary angiography.
Measured: 9 months
Secondary outcomes (20)
- Incidence of periprocedural complications: unplanned use of GP IIb/IIIa (Glycoprotein IIb/IIIa) inhibitors, vessel rupture, side branch occlusion, peri-procedural myocardial infarction
Periprocedural complications will be analyzed as combined endpoint and separately for all defined complication.
Measured: 9 months
- Comparison of rate of restenosis between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm))
The angiographic parameter will be compared separately in all defined subgroups.
Measured: 9 months
- Comparison of minimal luminal diameter between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm))
The angiographic parameter will be compared separately in all defined subgroups.
Measured: 9 months
- Comparison of diameter stenosis between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm))
The angiographic parameter will be compared separately in all defined subgroups.
Measured: 9 months
- Incidence of in-stent-restenosis, target lesion failure, target vessel revascularisation, stent thrombosis in in-hospital and long-term observation
Four clinical complications will be compared separately between study groups.
Measured: 9 months
- Early, late and very late probable or definite stent thrombosis
Detailed description of all events of stent thrombosis will be presented.
Measured: 9 months
- Cardiac and non-cardiac death in both groups
The frequency of deaths in both study group will be presented with differentiation according to the primary cause of the event.
Measured: 9 months
- Assessment of possibility vessel measurement and stent diameter/length choice based on this measurement performed in OCT (Optical Coherence Tomography)
The usefulness of OCT for stent choice will be analyzed. The frequency of procedures, when stent choice was done based on OCT measurements will be presented.
Measured: During index procedure.
- Result of index procedure assessment in OCT post procedure - lumen area.
The OCT parameter describing of stent implantation result during index procedure will be compared between study groups.
Measured: During index procedure.
- Result of index procedure assessment in OCT post procedure - stent area.
The OCT parameter describing of stent implantation result during index procedure will be compared between study groups.
Measured: During index procedure.
- Result of index procedure assessment in OCT post procedure - struts apposition assessment.
The OCT parameter - frequency of strut malapposition - describing of stent implantation result during index procedure will be compared between study groups.
Measured: During index procedure.
- Result of index procedure assessment in OCT post procedure - dissections.
The OCT parameter describing of stent implantation result during index procedure will be compared between study groups.
Measured: During index procedure.
- Result of index procedure assessment in OCT post procedure - stent expansion index.
The OCT parameter describing of stent implantation result during index procedure will be compared between study groups.
Measured: During index procedure.
- OCT assessment of long-term study results - lumen area.
The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.
Measured: 9 months
- OCT assessment of long-term study results - stent area.
The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.
Measured: 9 months
- OCT assessment of long-term study results - struts apposition assessment.
The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.
Measured: 9 months
- OCT assessment of long-term study results - neointimal volume.
The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.
Measured: 9 months
- OCT assessment of long-term study results - lumen volume.
The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.
Measured: 9 months
- Lumen volume change between index and 9M (nine months) FU in OCT.
The change of OCT parameter describing of stent implantation result will be compared between index procedure and in long term FU for both study groups.
Measured: 9 months
- Minimal lumen area change between index and 9M (nine months) FU in OCT.
The OCT parameter describing of stent implantation result will be compared between index procedure and in long term FU for both study groups.
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 posted18 May 2018
- Study startMar 2015
- Primary completionSep 2016
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-stent RestenosisStudies 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
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wojciech Zasada, Luzerner Kantonsspital
- Investigators
- Florim Cuculi, Principal investigator, Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529006
- Sponsor's protocol ID
- AbsorbISR
- Status last verified
- May 2018
- First submitted
- 19 Apr 2018
- Last updated
- 18 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis
- ClinicalTrials.gov ID
- NCT03529006
- Acronym / sponsor ID
- AbsorbISR
- Conditions
- In-stent Restenosis
- Keywords
- bioresorbable vascular scaffold, drug eluting balloon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jun 2020 (estimated)
- First posted
- 18 May 2018 (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.
The primary objective of this study is to demonstrate superiority of the Absorb scaffold compared to the Sequent Please Drug Coated Balloon when treating patients with In-Stent-Restenosis (ISR).
Detailed description
Absorb ISR is randomized-controlled trial of Absorb scaffold vs. Sequent Please drug coated balloon in an all-comers population with in-stent-restenosis. The patients will be randomized in a 1:1 fashion and the investigators intend to include 150 patients.
Repeat coronary angiography will be performed 9 months post intervention in all subjects. Optical coherence tomography will be performed at baseline and at 9 months in both groups.
All patients presenting with ISR and requiring percutaneous coronary intervention will be eligible to be included in this study. This will include patients with stable angina and those presenting with acute coronary syndrome (ACS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequent Please Drug Coated Balloon Group | Active comparator | Procedure: Sequent Please inflationFor Sequent Please Group, PCI (percutaneous coronary intervention) PCI procedure with Sequent Please inflation will be performed - drug eluting balloon will be used in the narrowed part of the artery. This method of treatment is one of the standard ones, which is typically used for treatment patients with diagnosis of in stent restenosis, the exact intervention and anesthesia procedures will be performed according to physician's usual practice. For bailout situation Xience stent implantation is possible. |
| Absorb Stent Group | Active comparator | Procedure: Absorb BVS implantationAbsorb scaffold group will be treated by PCI procedure with Absorb BVS implantation - implantation of bioresorbable vascular scaffold (Absorb). Coronary stent implantation for treatment in stent restenosis is one of the standard method of treatment this disease, but Absorb system has not been investigated in this indication yet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 18 years or above.
- Diagnosed with ISR requiring percutaneous coronary intervention: visual diameter stenosis > 70 % and/or Fractional Flow Reserve < 0.81 and/or non-invasive testing demonstrating ischemia. This real-life population with in-stent restenosis beside typical stable patients with ISR includes ACS patients with thrombus containing lesions, patients with multivessel disease, patients with ISR in non-infarct related artery, with ISR in BMS (bare metal stent), DES (drug eluting stent) or BVS, ISR in lesion previously treated by POBA (plain old balloon angioplasty), DEB or additional stent implantation.
- Double anti-platelet therapy for the duration of at least 12 months is considered possible at the time of intervention.
Key exclusion criteria (2 listed)
- Difficulty with deliver and implant the Absorb scaffold (e.g. highly calcified lesions).
- Patients who have any contraindications for using DEB (SeQent Please) or BVS (Absorb).
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 |
|---|---|---|
| Sequent Please inflationPCI procedure for treatment of ISR with DEB - Sequent Please - inflation | Procedure or surgery | Sequent Please Drug Coated Balloon Group |
| Absorb BVS implantationPCI procedure for treatment of ISR with Absorb BVS implantation | Procedure or surgery | Absorb Stent Group |
Primary outcome
Angiographic late lumen loss at 9 months
Time frame: 9 months
Late lumen loss will be calculated based on index and control coronary angiography.
20 secondary outcomes
- Incidence of periprocedural complications: unplanned use of GP IIb/IIIa (Glycoprotein IIb/IIIa) inhibitors, vessel rupture, side branch occlusion, peri-procedural myocardial infarction
Time frame: 9 months
- Comparison of rate of restenosis between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm))
Time frame: 9 months
- Comparison of minimal luminal diameter between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm))
Time frame: 9 months
- Comparison of diameter stenosis between both groups and in specific populations (patients with acute coronary syndromes, patients with diabetes, patients with long lesions (> 25 mm))
Time frame: 9 months
- Incidence of in-stent-restenosis, target lesion failure, target vessel revascularisation, stent thrombosis in in-hospital and long-term observation
Time frame: 9 months
- Early, late and very late probable or definite stent thrombosis
Time frame: 9 months
- Cardiac and non-cardiac death in both groups
Time frame: 9 months
- Assessment of possibility vessel measurement and stent diameter/length choice based on this measurement performed in OCT (Optical Coherence Tomography)
Time frame: During index procedure.
- Result of index procedure assessment in OCT post procedure - lumen area.
Time frame: During index procedure.
- Result of index procedure assessment in OCT post procedure - stent area.
Time frame: During index procedure.
- Result of index procedure assessment in OCT post procedure - struts apposition assessment.
Time frame: During index procedure.
- Result of index procedure assessment in OCT post procedure - dissections.
Time frame: During index procedure.
- Result of index procedure assessment in OCT post procedure - stent expansion index.
Time frame: During index procedure.
- OCT assessment of long-term study results - lumen area.
Time frame: 9 months
- OCT assessment of long-term study results - stent area.
Time frame: 9 months
- OCT assessment of long-term study results - struts apposition assessment.
Time frame: 9 months
- OCT assessment of long-term study results - neointimal volume.
Time frame: 9 months
- OCT assessment of long-term study results - lumen volume.
Time frame: 9 months
- Lumen volume change between index and 9M (nine months) FU in OCT.
Time frame: 9 months
- Minimal lumen area change between index and 9M (nine months) FU in OCT.
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
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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.
Florim Cuculi principal investigator
Luzerner Kantonsspital
Questions about this trial
What is this clinical trial studying?
A study testing Sequent Please inflation and Absorb BVS implantation in people with In-stent Restenosis, run by Luzerner Kantonsspital.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Angiographic late lumen loss at 9 months (time frame: 9 months). 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 18 May 2018.