Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02474485
• Date of registration: 11/06/2015
• Prospective Registration: No
• Primary sponsor: SIS Medical AG
• Public title: Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR AbsorbISR
• Scientific title: Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis
• Date of first enrolment: March 2015
• Target sample size: 53
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/show/NCT02474485
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Florim Cuculi, Prof. dr

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Coronary Restenosis

Intervention(s)

Device: DEB Sequent Please inflation.

Procedure: OCT visualization.

Device: BVS Absorb implantation.

Other: Clinical observation.

Procedure: Control coronary angiography.

Primary Outcome(s)

Angiographic late lumen loss at 9 month follow-up. [Time Frame: At 9 month follow up.]

Secondary Outcome(s)

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.]

Incidence of target vessel revascularisation in long-term observation. [Time Frame: During 60 month follow-up.]

OCT assessment of long-term study results (lumen/stent area, struts assessment, neointimal volume, lumen volume). [Time Frame: At 9 month follow-up.]

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.]

Incidence of periprocedural complications: vessel rupture. [Time Frame: Participants will be followed for the duration of index procedure, an expected average of 1 hour.]

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.]

Incidence of target lesion failure in long-term observation. [Time Frame: During 60 month follow-up.]

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.]

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.]

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.]

Cardiac and non-cardiac death in both groups. [Time Frame: During 60 month follow-up.]

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.]

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.]

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.]

Incidence of in-stent-restenosis in long-term observation. [Time Frame: During 60 month follow-up.]

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.]

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.]

Incidence of stent thrombosis in long-term observation. [Time Frame: During 60 month follow-up.]

Secondary ID(s)

AbsorbISR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors