Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529006
Recruitment Status : Unknown
Verified May 2018 by Wojciech Zasada, Luzerner Kantonsspital.
Recruitment status was:  Active, not recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Wojciech Zasada, 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).

Condition or disease Intervention/treatment Phase
In-stent Restenosis Procedure: Sequent Please inflation Procedure: Absorb BVS implantation Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Absorb Bioresorbable Scaffold vs. Drug Coated Balloon for Treatment Of In-Stent-Restenosis
Study Start Date : March 2015
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Active Comparator: Sequent Please Drug Coated Balloon Group
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.
Procedure: Sequent Please inflation
PCI procedure for treatment of ISR with DEB - Sequent Please - inflation

Active Comparator: Absorb Stent Group
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.
Procedure: Absorb BVS implantation
PCI procedure for treatment of ISR with Absorb BVS implantation




Primary Outcome Measures :
  1. Angiographic late lumen loss at 9 months [ Time Frame: 9 months ]
    Late lumen loss will be calculated based on index and control coronary angiography.


Secondary Outcome Measures :
  1. - Incidence of periprocedural complications: unplanned use of GP IIb/IIIa (Glycoprotein IIb/IIIa) inhibitors, vessel rupture, side branch occlusion, peri-procedural myocardial infarction [ Time Frame: 9 months ]
    Periprocedural complications will be analyzed as combined endpoint and separately for all defined complication.

  2. - 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: 9 months ]
    The angiographic parameter will be compared separately in all defined subgroups.

  3. - 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: 9 months ]
    The angiographic parameter will be compared separately in all defined subgroups.

  4. - 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: 9 months ]
    The angiographic parameter will be compared separately in all defined subgroups.

  5. - Incidence of in-stent-restenosis, target lesion failure, target vessel revascularisation, stent thrombosis in in-hospital and long-term observation [ Time Frame: 9 months ]
    Four clinical complications will be compared separately between study groups.

  6. - Early, late and very late probable or definite stent thrombosis [ Time Frame: 9 months ]
    Detailed description of all events of stent thrombosis will be presented.

  7. - Cardiac and non-cardiac death in both groups [ Time Frame: 9 months ]
    The frequency of deaths in both study group will be presented with differentiation according to the primary cause of the event.

  8. - Assessment of possibility vessel measurement and stent diameter/length choice based on this measurement performed in OCT (Optical Coherence Tomography) [ Time Frame: 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.

  9. - Result of index procedure assessment in OCT post procedure - lumen area. [ Time Frame: During index procedure. ]
    The OCT parameter describing of stent implantation result during index procedure will be compared between study groups.

  10. - Result of index procedure assessment in OCT post procedure - stent area. [ Time Frame: During index procedure. ]
    The OCT parameter describing of stent implantation result during index procedure will be compared between study groups.

  11. - Result of index procedure assessment in OCT post procedure - struts apposition assessment. [ Time Frame: During index procedure. ]
    The OCT parameter - frequency of strut malapposition - describing of stent implantation result during index procedure will be compared between study groups.

  12. - Result of index procedure assessment in OCT post procedure - dissections. [ Time Frame: During index procedure. ]
    The OCT parameter describing of stent implantation result during index procedure will be compared between study groups.

  13. - Result of index procedure assessment in OCT post procedure - stent expansion index. [ Time Frame: During index procedure. ]
    The OCT parameter describing of stent implantation result during index procedure will be compared between study groups.

  14. - OCT assessment of long-term study results - lumen area. [ Time Frame: 9 months ]
    The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.

  15. - OCT assessment of long-term study results - stent area. [ Time Frame: 9 months ]
    The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.

  16. - OCT assessment of long-term study results - struts apposition assessment. [ Time Frame: 9 months ]
    The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.

  17. - OCT assessment of long-term study results - neointimal volume. [ Time Frame: 9 months ]
    The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.

  18. - OCT assessment of long-term study results - lumen volume. [ Time Frame: 9 months ]
    The OCT parameter describing of stent implantation result in long term FU (follow-up) will be compared between study groups.

  19. - Lumen volume change between index and 9M (nine months) FU in OCT. [ Time Frame: 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.

  20. - Minimal lumen area change between index and 9M (nine months) FU in OCT. [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529006


Sponsors and Collaborators
Luzerner Kantonsspital
Investigators
Layout table for investigator information
Principal Investigator: Florim Cuculi Luzerner Kantonsspital
Layout table for additonal information
Responsible Party: Wojciech Zasada, Clinical Trial Administrator, Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT03529006    
Other Study ID Numbers: AbsorbISR
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Keywords provided by Wojciech Zasada, Luzerner Kantonsspital:
bioresorbable vascular scaffold
drug eluting balloon