AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting bioresorbable stent scaffold Absorb® vs. balloon angioplasty with drug eluting balloon Sequent Please®.
This is randomized-controlled trial of Absorb® Bioresorbable Vascular Scaffold (BVS) vs. Sequent Please® drug coated balloon in an all-comers population with in-stent-restenosis (ISR). The patients will be randomized in a 1:1 fashion and the investigators intend to include 150 patients. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Absorb bioresorbable vascular scaffold will be implanted to treat in stent restenosis in target vessel.
Inflation of drug eluting balloon Sequent Please will be performed to treat in stent restenosis in target vessel.
Control coronary angiography will be performed at 9 month follow-up.
Luzernen Kantonsspital, Spitalstrasse 16
Lucerne, Switzerland
Angiographic late lumen loss at 9 month follow-up.
Angiographic late lumen loss will be compared between both study groups.
Time frame: At 9 month follow up.
Incidence of periprocedural complications: unplanned use of GP IIb/IIIa inhibitors.
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of periprocedural complications: vessel rupture.
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of periprocedural complications: side branch occlusion.
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of periprocedural complications: peri-procedural myocardial infarction.
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
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: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
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: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
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)).
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OCT visualization will be performed during index procedure and at 9 month follow-up.
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.
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Incidence of in-stent-restenosis in long-term observation.
Time frame: During 60 month follow-up.
Incidence of target lesion failure in long-term observation.
Time frame: During 60 month follow-up.
Incidence of target vessel revascularisation in long-term observation.
Time frame: During 60 month follow-up.
Incidence of stent thrombosis in long-term observation.
Time frame: During 60 month follow-up.
Occurence of stent thrombosis (defined as early, late and very late probable or definite according to ARC definition).
Time frame: During 60 month follow-up.
Cardiac and non-cardiac death in both groups.
Time frame: During 60 month follow-up.
Assessment of possibility vessel measurement and stent diameter/length choice based on these measurement in optical coherence tomography (OCT).
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Result of index procedure assessment in OCT post procedure (lumen/stent area, struts assessment, dissections, stent expansion).
Time frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.
OCT assessment of long-term study results (lumen/stent area, struts assessment, neointimal volume, lumen volume).
Time frame: At 9 month follow-up.
Lumen volume change between index and 9 month follow-up OCT.
Time frame: OCT parameters change will be assessed between index hospitalization and 9 month follow-up.
Minimal lumen area change between index and 9 month follow-up OCT.
Time frame: OCT parameters change will be assessed between index hospitalization and 9 month follow-up.