Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR
NCT ID: NCT02474485
Last Updated: 2018-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
SUSPENDED
NA
53 participants
INTERVENTIONAL
2015-03-31
2021-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis
NCT03529006
ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis
NCT02486068
Everolimus-Eluting Bioresorbable Scaffolds Versus Everolimus-Eluting Metallic Stents for Diffuse Long Coronary Artery Disease
NCT02831205
ABSORB II Randomized Controlled Trial
NCT01425281
A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)
NCT01923740
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
The primary objective of this study is to demonstrate superiority of the Absorb® bioresorbable scaffold compared to the Sequent Please® Drug Coated Balloon when treating patients with In-Stent-Restenosis regards to primary endpoint - angiographic late lumen loss at 9 month follow-up.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BVS - Absorb
BVS - Absorb scaffold group will be treated by implantation of drug eluting bioresorbable vascular scaffold (Absorb®). In this arm following interventions will be performed:
* BVS Absorb implantation. For in stent restenosis treatment during index procedure.
* OCT visualization.During index procedure and at 9 month follow-up.
* Control coronary angiography. Control angiography will be performed at 9 month follow-up.
* Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up.
BVS Absorb implantation.
Absorb bioresorbable vascular scaffold will be implanted to treat in stent restenosis in target vessel.
Control coronary angiography.
Control coronary angiography will be performed at 9 month follow-up.
OCT visualization.
OCT visualization will be performed during index procedure and at 9 month follow-up.
Clinical observation.
Patients will be informed that Investigator will contact them at 12, 24 and 60 months after the procedure. Investigator will collect information regarding clinical status of Patients, cardiac medications and any adverse events that occurred since the last follow-up.
DEB - Sequent Please
In DEB - Sequent Please Group, dilatation of drug eluting balloon Sequent Please ® will be used for treatment of the narrowed part of the artery. In this arm following interventions will be performed:
* DEB Sequent Please inflation. For in stent restenosis treatment during index procedure.
* OCT visualization.During index procedure and at 9 month follow-up.
* Control coronary angiography. Control angiography will be performed at 9 month follow-up.
* Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up.
DEB Sequent Please inflation.
Inflation of drug eluting balloon Sequent Please will be performed to treat in stent restenosis in target vessel.
Control coronary angiography.
Control coronary angiography will be performed at 9 month follow-up.
OCT visualization.
OCT visualization will be performed during index procedure and at 9 month follow-up.
Clinical observation.
Patients will be informed that Investigator will contact them at 12, 24 and 60 months after the procedure. Investigator will collect information regarding clinical status of Patients, cardiac medications and any adverse events that occurred since the last follow-up.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BVS Absorb implantation.
Absorb bioresorbable vascular scaffold will be implanted to treat in stent restenosis in target vessel.
DEB Sequent Please inflation.
Inflation of drug eluting balloon Sequent Please will be performed to treat in stent restenosis in target vessel.
Control coronary angiography.
Control coronary angiography will be performed at 9 month follow-up.
OCT visualization.
OCT visualization will be performed during index procedure and at 9 month follow-up.
Clinical observation.
Patients will be informed that Investigator will contact them at 12, 24 and 60 months after the procedure. Investigator will collect information regarding clinical status of Patients, cardiac medications and any adverse events that occurred since the last follow-up.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 bare metal stent (BMS), drug eluting stent (DES) or bioresorbable vascular scaffold (BVS), ISR in lesion previously treated by plain old balloon angioplasty (POBA), drug eluting balloon (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
Exclusion Criteria
* Patients who have any contraindications for using DEB (SeQent Please) or BVS (Absorb) specified in instructions for use are not able to participate in this study.
* Women with childbearing potential must have a negative result of pregnancy test and they must use an effective contraception method for at least 12 months after study procedure.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
SIS Medical AG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Florim Cuculi, Prof. dr
Role: PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Luzernen Kantonsspital, Spitalstrasse 16
Lucerne, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AbsorbISR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.