Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis

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).

Study Overview

• Status: Unknown
• Conditions: In-stent Restenosis
• Intervention / Treatment: Procedure: Sequent Please inflation; Procedure: Absorb BVS implantation

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sequent Please Drug Coated Balloon Group; 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.	Procedure: Sequent Please inflation; PCI procedure for treatment of ISR with DEB - Sequent Please - inflation
Active Comparator: Absorb Stent Group; 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.	Procedure: Absorb BVS implantation; PCI procedure for treatment of ISR with Absorb BVS implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic late lumen loss at 9 months	Late lumen loss will be calculated based on index and control coronary angiography.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- 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.	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.	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.	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.	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.	9 months
- Early, late and very late probable or definite stent thrombosis	Detailed description of all events of stent thrombosis will be presented.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	9 months

Collaborators and Investigators

• Sponsor: Luzerner Kantonsspital
• Investigators: Principal Investigator: Florim Cuculi, Luzerner Kantonsspital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: May 7, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: drug eluting balloon; bioresorbable vascular scaffold
• Other Study ID Numbers: AbsorbISR