Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR

Coronary Artery Disease Clinical Trial

— AbsorbISR  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02474485
• Other study ID #: AbsorbISR
• Status: Suspended
• Phase: N/A
• First received: June 11, 2015
• Last updated: March 8, 2018
• Start date: March 2015
• Est. completion date: June 2021

Study information

• Verified date: March 2018
• Source: SIS Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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®.

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 53
• Est. completion date: June 2021
• Est. primary completion date: May 2018
• 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 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:

• The participant may not enter the study if the interventionist has doubts that he is not able to deliver and implant the Absorb scaffold (e.g. highly calcified lesions).

• 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Myocardial Ischemia

Intervention

Device:
• 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.

Procedure:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
Switzerland	Luzernen Kantonsspital, Spitalstrasse 16	Luzern

Sponsors (1)

Lead Sponsor	Collaborator
SIS Medical AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic late lumen loss at 9 month follow-up.	Angiographic late lumen loss will be compared between both study groups.	At 9 month follow up.
Secondary	Incidence of periprocedural complications: unplanned use of GP IIb/IIIa inhibitors.		Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Secondary	Incidence of periprocedural complications: vessel rupture.		Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Secondary	Incidence of periprocedural complications: side branch occlusion.		Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Secondary	Incidence of periprocedural complications: peri-procedural myocardial infarction.		Participants will be followed for the duration of index procedure, an expected average of 1 hour.
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)).		Participants will be followed for the duration of index procedure, an expected average of 1 hour.
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)).		Participants will be followed for the duration of index procedure, an expected average of 1 hour.
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)).		Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Secondary	Incidence of in-stent-restenosis in long-term observation.		During 60 month follow-up.
Secondary	Incidence of target lesion failure in long-term observation.		During 60 month follow-up.
Secondary	Incidence of target vessel revascularisation in long-term observation.		During 60 month follow-up.
Secondary	Incidence of stent thrombosis in long-term observation.		During 60 month follow-up.
Secondary	Occurence of stent thrombosis (defined as early, late and very late probable or definite according to ARC definition).		During 60 month follow-up.
Secondary	Cardiac and non-cardiac death in both groups.		During 60 month follow-up.
Secondary	Assessment of possibility vessel measurement and stent diameter/length choice based on these measurement in optical coherence tomography (OCT).		Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Secondary	Result of index procedure assessment in OCT post procedure (lumen/stent area, struts assessment, dissections, stent expansion).		Participants will be followed for the duration of index procedure, an expected average of 1 hour.
Secondary	OCT assessment of long-term study results (lumen/stent area, struts assessment, neointimal volume, lumen volume).		At 9 month follow-up.
Secondary	Lumen volume change between index and 9 month follow-up OCT.		OCT parameters change will be assessed between index hospitalization and 9 month follow-up.
Secondary	Minimal lumen area change between index and 9 month follow-up OCT.		OCT parameters change will be assessed between index hospitalization and 9 month follow-up.