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

In-stent Restenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03529006
• Other study ID #: AbsorbISR
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: June 2020

Study information

• Verified date: May 2018
• Source: Luzerner Kantonsspital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: June 2020
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• In-stent Restenosis

Intervention

Procedure:
• Sequent Please inflation
PCI procedure for treatment of ISR with DEB - Sequent Please - inflation
• Absorb BVS implantation
PCI procedure for treatment of ISR with Absorb BVS implantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Luzerner Kantonsspital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic late lumen loss at 9 months	Late lumen loss will be calculated based on index and control coronary angiography.	9 months
Secondary	- 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
Secondary	- 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
Secondary	- 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
Secondary	- 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
Secondary	- 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
Secondary	- Early, late and very late probable or definite stent thrombosis	Detailed description of all events of stent thrombosis will be presented.	9 months
Secondary	- 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
Secondary	- 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.
Secondary	- 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.
Secondary	- 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.
Secondary	- 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.
Secondary	- 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.
Secondary	- 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.
Secondary	- 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
Secondary	- 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
Secondary	- 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
Secondary	- 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
Secondary	- 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
Secondary	- 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
Secondary	- 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