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Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR (AbsorbISR)

Primary Purpose

Coronary Artery Disease, Coronary Restenosis

Status

Suspended

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

BVS Absorb implantation.

DEB Sequent Please inflation.

Control coronary angiography.

OCT visualization.

Clinical observation.

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring bioresorbable vascular scaffold, Absorb, drug eluting balloon, percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Luzernen Kantonsspital, Spitalstrasse 16

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

BVS - Absorb

DEB - Sequent Please

Arm Description

BVS - Absorb scaffold group will be treated by implantation of drug eluting bioresorbable vascular scaffold (Absorb®). In this arm following interventions will be performed: BVS Absorb implantation. For in stent restenosis treatment during index procedure. OCT visualization.During index procedure and at 9 month follow-up. Control coronary angiography. Control angiography will be performed at 9 month follow-up. Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up.

In DEB - Sequent Please Group, dilatation of drug eluting balloon Sequent Please ® will be used for treatment of the narrowed part of the artery. In this arm following interventions will be performed: DEB Sequent Please inflation. For in stent restenosis treatment during index procedure. OCT visualization.During index procedure and at 9 month follow-up. Control coronary angiography. Control angiography will be performed at 9 month follow-up. Clinical observation. Clinical observation will be performed at 9, 12 and 60 month follow-up.

Outcomes

Primary Outcome Measures

Angiographic late lumen loss at 9 month follow-up.

Angiographic late lumen loss will be compared between both study groups.

Secondary Outcome Measures

Incidence of periprocedural complications: unplanned use of GP IIb/IIIa inhibitors.

Incidence of periprocedural complications: vessel rupture.

Incidence of periprocedural complications: side branch occlusion.

Incidence of periprocedural complications: peri-procedural myocardial infarction.

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)).

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)).

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)).

Incidence of in-stent-restenosis in long-term observation.

Incidence of target lesion failure in long-term observation.

Incidence of target vessel revascularisation in long-term observation.

Incidence of stent thrombosis in long-term observation.

Occurence of stent thrombosis (defined as early, late and very late probable or definite according to ARC definition).

Cardiac and non-cardiac death in both groups.

Assessment of possibility vessel measurement and stent diameter/length choice based on these measurement in optical coherence tomography (OCT).

Result of index procedure assessment in OCT post procedure (lumen/stent area, struts assessment, dissections, stent expansion).

OCT assessment of long-term study results (lumen/stent area, struts assessment, neointimal volume, lumen volume).

Lumen volume change between index and 9 month follow-up OCT.

Minimal lumen area change between index and 9 month follow-up OCT.

Full Information

NCT ID

NCT02474485

First Posted

June 11, 2015

Last Updated

March 8, 2018

Sponsor

SIS Medical AG

1. Study Identification

Unique Protocol Identification Number

NCT02474485

Brief Title

Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR

Acronym

AbsorbISR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Suspended

Why Stopped

Information of other studies with Abseb bioresorbable scaffolds showed a higher thrombotic risk than before, the risk for the Patients is estimated too high

Study Start Date

March 2015 (undefined)

Primary Completion Date

May 2018 (Anticipated)

Study Completion Date

June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SIS Medical AG

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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®.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Coronary Restenosis

Keywords

bioresorbable vascular scaffold, Absorb, drug eluting balloon, percutaneous coronary intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BVS - Absorb

Arm Type

Active Comparator

Arm Description

Arm Title

DEB - Sequent Please

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

BVS Absorb implantation.

Intervention Description

Absorb bioresorbable vascular scaffold will be implanted to treat in stent restenosis in target vessel.

Intervention Type

Device

Intervention Name(s)

DEB Sequent Please inflation.

Intervention Description

Inflation of drug eluting balloon Sequent Please will be performed to treat in stent restenosis in target vessel.

Intervention Type

Procedure

Intervention Name(s)

Control coronary angiography.

Intervention Description

Control coronary angiography will be performed at 9 month follow-up.

Intervention Type

Procedure

Intervention Name(s)

OCT visualization.

Intervention Description

OCT visualization will be performed during index procedure and at 9 month follow-up.

Intervention Type

Other

Intervention Name(s)

Clinical observation.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Angiographic late lumen loss at 9 month follow-up.

Description

Angiographic late lumen loss will be compared between both study groups.

Time Frame

At 9 month follow up.

Secondary Outcome Measure Information:

Title

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.

Title

Incidence of periprocedural complications: vessel rupture.

Time Frame

Participants will be followed for the duration of index procedure, an expected average of 1 hour.

Title

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.

Title

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.

Title

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.

Title

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.

Title

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)).

Time Frame

Participants will be followed for the duration of index procedure, an expected average of 1 hour.

Title

Incidence of in-stent-restenosis in long-term observation.

Time Frame

During 60 month follow-up.

Title

Incidence of target lesion failure in long-term observation.

Time Frame

During 60 month follow-up.

Title

Incidence of target vessel revascularisation in long-term observation.

Time Frame

During 60 month follow-up.

Title

Incidence of stent thrombosis in long-term observation.

Time Frame

During 60 month follow-up.

Title

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.

Title

Cardiac and non-cardiac death in both groups.

Time Frame

During 60 month follow-up.

Title

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.

Title

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.

Title

OCT assessment of long-term study results (lumen/stent area, struts assessment, neointimal volume, lumen volume).

Time Frame

At 9 month follow-up.

Title

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.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florim Cuculi, Prof. dr

Official's Role

Principal Investigator

Facility Information:

Facility Name

Luzernen Kantonsspital, Spitalstrasse 16

City

Luzern

ZIP/Postal Code

6000

Country

Switzerland

12. IPD Sharing Statement

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Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR

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