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

Not Applicable

• Conditions: In-stent Restenosis
• Interventions: Procedure: Absorb BVS implantation; Procedure: Sequent Please inflation

• Registration Number: NCT03529006
• Lead Sponsor: Luzerner Kantonsspital

Brief 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).

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 Timeline

• Study Start: 2015-03
• Primary Completion: 2016-09
• Study First Submitted: 2018-04-19
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-07
• Last Update Submitted: 2018-05-07
• Study First Posted: 2018-05-18
• Last Update Posted: 2018-05-18
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

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.

Read More

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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absorb Stent Group	Absorb BVS implantation	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.
Sequent Please Drug Coated Balloon Group	Sequent Please inflation	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.

Primary Outcome Measures

Name	Time	Method
Angiographic late lumen loss at 9 months	9 months	Late lumen loss will be calculated based on index and control coronary angiography.

Secondary Outcome Measures

Name	Time	Method
- OCT assessment of long-term study results - lumen volume.	9 months	The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.
- Incidence of in-stent-restenosis, target lesion failure, target vessel revascularisation, stent thrombosis in in-hospital and long-term observation	9 months	Four clinical complications will be compared separately between study groups.
- Early, late and very late probable or definite stent thrombosis	9 months	Detailed description of all events of stent thrombosis will be presented.
- Cardiac and non-cardiac death in both groups	9 months	The frequency of deaths in both study group will be presented with differentiation according to the primary cause of the event.
- Result of index procedure assessment in OCT post procedure - struts apposition assessment.	During index procedure.	The OCT parameter - frequency of strut malapposition - describing of stent implantation result during index procedure will be compared between study groups.
- Result of index procedure assessment in OCT post procedure - dissections.	During index procedure.	The OCT parameter describing of stent implantation result during index procedure will be compared between study groups.
- 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))	9 months	The angiographic parameter will be compared separately in all defined subgroups.
- OCT assessment of long-term study results - lumen area.	9 months	The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.
- Incidence of periprocedural complications: unplanned use of GP IIb/IIIa (Glycoprotein IIb/IIIa) inhibitors, vessel rupture, side branch occlusion, peri-procedural myocardial infarction	9 months	Periprocedural complications will be analyzed as combined endpoint and separately for all defined complication.
- 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))	9 months	The angiographic parameter will be compared separately in all defined subgroups.
- 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))	9 months	The angiographic parameter will be compared separately in all defined subgroups.
- Assessment of possibility vessel measurement and stent diameter/length choice based on this measurement performed in OCT (Optical Coherence Tomography)	During index procedure.	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.
- Result of index procedure assessment in OCT post procedure - stent area.	During index procedure.	The OCT parameter describing of stent implantation result during index procedure will be compared between study groups.
- Result of index procedure assessment in OCT post procedure - stent expansion index.	During index procedure.	The OCT parameter describing of stent implantation result during index procedure will be compared between study groups.
- OCT assessment of long-term study results - struts apposition assessment.	9 months	The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.
- Lumen volume change between index and 9M (nine months) FU in OCT.	9 months	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.
- Result of index procedure assessment in OCT post procedure - lumen area.	During index procedure.	The OCT parameter describing of stent implantation result during index procedure will be compared between study groups.
- OCT assessment of long-term study results - stent area.	9 months	The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.
- OCT assessment of long-term study results - neointimal volume.	9 months	The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.
- Minimal lumen area change between index and 9M (nine months) FU in OCT.	9 months	The OCT parameter describing of stent implantation result will be compared between index procedure and in long term FU for both study groups.