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Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon Pre-dilatation (RIBS VI Scoring)

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ClinicalTrials.gov Identifier: NCT03069066
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Collaborators:
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Instituto de Investigación Sanitaria Hospital Universitario de la Princesa
Abbott Medical Devices
Terumo Medical Corporation
Information provided by (Responsible Party):
Fernando Alfonso, Spanish Society of Cardiology

Brief Summary:
Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study will assess the efficacy of Bioresorbable Vascular Scaffolds (BVS) (Abbott Vascular) in the treatment of patients suffering from ISR after scoring balloon pre-dilatation.

Condition or disease Intervention/treatment Phase
Coronary In-stent Restenosis Device: Bioresorbable vascular scaffold. Absorb GT1 (Abbott) Phase 4

Detailed Description:

Treatment of patients with ISR remains a challenge. Currently both drug-eluting stents (DES) and drug-coated balloons (DCB) are considered as the strategies of choice in this setting. However, data on the value of BVS in patients with ISR is scarce. BVS are very effective to inhibit neointimal proliferation and they avoid the need of implanting a new permanent metal layer. Accordingly, currently, there is a major interest to elucidate the potential value of BVS in patients with ISR. The use of scoring balloon pre-dilatation has not been studied previously in this setting.

This prospective Spanish multicenter study will assess the clinical and angiographic outcome of patients with ISR treated with BVS with scoring balloon pre-dilatation. BVS will be implanted in selected patients (fulfilling inclusion and exclusion criteria) presenting with either BMS-ISR or DES-ISR. Care will be paid to ensure device optimization. Scoring balloon pre-dilatation is mandatory. Angiographic follow-up will be obtained at 6-9 months. A centralized angiographic corelab will be used to provide QCA measurements. Clinical follow-up will be also obtained at 1 year and then yearly. Clinical events will be adjudicated by an independent Clinical Event Committee.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Bioresorbable Vascular Scaffold Treatment With Scoring Balloon Pre-dilatation in Patients With In-stent Restenosis
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: BVS implantation in patients with ISR
BVS implantation in patients with ISR after scoring balloon pre-dilatation
Device: Bioresorbable vascular scaffold. Absorb GT1 (Abbott)



Primary Outcome Measures :
  1. Minimal lumen diameter as assessed by quantitative coronary angiography at late angiographic follow-up [ Time Frame: angiographic follow-up at 6-9 months ]
    This is a single arm study and results will be analyzed this arm. However, the angiographic and clinical results will be also compared with those obtained in other arms of previous RIBS trials. In particular results will be compared with those found in the RIBS VI study.

  2. Combined clinical end-point (cardiac death, myocardial infarction and target vessel revascularization) [ Time Frame: 1 year of clinical follow-up ]

    This is a well-accepted outcome measure of individual clinical end-points. Definition of myocardial infarction is similar to that used in previous RIBS studies.

    The occurrence of ANY of these events will qualify for the combined event. That is, Cardiac death OR Myocardial Infarctio OR target vessel revascularization. (for the cobined end point the first event will be censored for each patient and other subsequent events will not apply). For time related statistics, the first event will be censored in the KM curves. In addition to that, the time and occurrence of each individual event will be also analyzed.

    The same strategy will be followed for the other combined clinical outcome measures that, again, are classically defined in this field.



Secondary Outcome Measures :
  1. Acute gain [ Time Frame: procedure ]
    Change in the minimal lumen diameter from baseline to the final procedural angiogram. Acute angiographic parameter

  2. Minimal lumen diameter [ Time Frame: procedure ]
    Acute angiographic parameter

  3. Percent diameter stenosis [ Time Frame: procedure ]
    Acute angiographic parameter

  4. Restenosis rate [ Time Frame: 6-9 months ]
    Late angiographic parameter

  5. Percent diameter stenosis [ Time Frame: 6-9 months ]
    Late angiographic parameter

  6. Late loss [ Time Frame: 6-9 months ]
    Change in minimal lumen diameter from the final procedure to the follow-up angiogram at 6-9 months. Late angiographic parameter.

  7. Net gain [ Time Frame: 6-9 months ]
    Is the difference between acute gain and late loss. Late angiographic parameter

  8. Loss index [ Time Frame: 6-9 months ]
    Late angiographic parameter

  9. Combined clinical outcome measure (cardiac death, myocardial infarction, target lesion revascularization) [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]

    This is a well-accepted outcome measure of individual clinical end-points. Definition of myocardial infarction is similar to that used in previous RIBS studies. The occurrence of ANY of these events will qualify for the combined event. That is, Cardiac death OR Myocardial Infarctio OR target vessel revascularization. (for the cobined end point the first event will be censored for each patient and other subsequent events will not apply). For time related statistics, the first event will be censored in the KM curves. In addition to that, the time and occurrence of each individual event will be also analyzed.

    The same strategy will be followed for the other combined clinical outcome measures that, again, are classically defined in this field.


  10. Cardiac death [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome

  11. Total mortality [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome

  12. Myocardial infarction [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome

  13. Target vessel revascularization [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome

  14. Target lesion revascularization [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome

  15. Stent thrombosis [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome

  16. Major bleeding [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome

  17. Target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    This is a well-accepted outcome measure of individual clinical end-points



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

In-stent restenosis with ischemia. Signed Informed Consent IRB approval

INCLUSION CRITERIA:

PATIENT

  • Age > 20 and < 85 years of age
  • Acceptance of late angiographic evaluation
  • Angina or objective evidence of ischemia

LESION

  • ISR (>50% diameter stenosis on visual assessment)
  • Previous stent location known

EXCLUSION CRITERIA:

PATIENT

  • Inclusion in other clinical research protocol
  • Allergy to antiplatelet agents
  • Women in childbearing age
  • Severe associated systemic diseases (including renal or liver failure) or diseases affecting life expectancy
  • Recent myocardial infarction
  • Time from index stent implantation < 1 month
  • Anticipated difficulties for late angiographic evaluation

LESION

  • Stent thrombosis or large thrombus within the stent
  • Angiographic failure during initial stent implantation or persistence or large dissection.
  • Severe tortuosity or calcification or major difficulties during previous stent implantation
  • Vessel diameter < 2.25 mm (visual assessment)
  • Stenosis outside stent stent edge (edge ISR are eligible)
  • Very diffuse ISR (>30 mm in length)

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): NCT03069066


Locations
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Spain
Complexo Universitario Hospitalario de Santiago Recruiting
Santiago de Compostela, A Coruña, Spain, 15006
Contact: Ramiro Trillo, MD       ramirotrillo@mac.com   
Hospital Central de Asturias Recruiting
Oviedo, Asturias, Spain, 33006
Contact: Raquel del Valle, MD       raqueldelvalle@gmail.com   
Hospital Universitari de Bellvitge Recruiting
L´Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact: Rafael Romaguera, MD       rafaromaguera@gmail.com   
Hospital Universitario Puerta de Hierro Recruiting
Majadahonda, Madrid, Spain, 28222
Contact: Arturo Garcia-Touchard, MD       agtouchard@gmail.com   
Hospital Universitario de Canarias Recruiting
San Cristobal de La Laguna, Santa Cruz de Tenerife, Spain, 38320
Contact: Francisco Ignacio Ga Bosa, MD       franbosa@ull.edu.es   
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Vicens Marti, MD       vmarti@santpau.cat   
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Monica Masotti, MD       masotti@clinic.ub.es   
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain, 18014
Contact: Rafael Melgares, MD       rafael.melgares.sspa@juntadeandalucia.es   
Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28006
Contact: Fernando Alfonso Manterola, MD, PhD       falf@hotmail.com   
Contact: Javier Cuesta Cuesta, MD       javicuestacuesta@hotmail.com   
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Maite Velazquez, MD       maitevel05@gmail.com   
Sponsors and Collaborators
Spanish Society of Cardiology
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Instituto de Investigación Sanitaria Hospital Universitario de la Princesa
Abbott Medical Devices
Terumo Medical Corporation

Publications:
Alfonso F, Pérez-Vizcayno MJ, Cárdenas A, García Del Blanco B, Seidelberger B, Iñiguez A, Gómez-Recio M, Masotti M, Velázquez MT, Sanchís J, García-Touchard A, Zueco J, Bethencourt A, Melgares R, Cequier A, Dominguez A, Mainar V, López-Mínguez JR, Moreu J, Martí V, Moreno R, Jiménez-Quevedo P, Gonzalo N, Fernández C, Macaya C; RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology. A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-eluting stent). J Am Coll Cardiol. 2014 Apr 15;63(14):1378-86. doi: 10.1016/j.jacc.2013.12.006. Epub 2014 Jan 8.

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Responsible Party: Fernando Alfonso, MD, Spanish Society of Cardiology
ClinicalTrials.gov Identifier: NCT03069066     History of Changes
Other Study ID Numbers: RIBS VI scoring
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fernando Alfonso, Spanish Society of Cardiology:
In-stent restenosis
Bioresorbable vascular scaffold
Stent
Drug-eluting stent
Coronary angiography
Scoring balloon
Additional relevant MeSH terms:
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Aneurysm
Dilatation, Pathologic
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical