Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 27, 2017
First Posted Date  ICMJE March 3, 2017
Last Update Posted Date March 3, 2017
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2017)
  • 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.
  • 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.
Change History Complete list of historical versions of study NCT03069066 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2017)
  • Acute gain [ Time Frame: procedure ]
    Change in the minimal lumen diameter from baseline to the final procedural angiogram. Acute angiographic parameter
  • Minimal lumen diameter [ Time Frame: procedure ]
    Acute angiographic parameter
  • Percent diameter stenosis [ Time Frame: procedure ]
    Acute angiographic parameter
  • Restenosis rate [ Time Frame: 6-9 months ]
    Late angiographic parameter
  • Percent diameter stenosis [ Time Frame: 6-9 months ]
    Late angiographic parameter
  • 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.
  • Net gain [ Time Frame: 6-9 months ]
    Is the difference between acute gain and late loss. Late angiographic parameter
  • Loss index [ Time Frame: 6-9 months ]
    Late angiographic parameter
  • 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.
  • Cardiac death [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • Total mortality [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • Myocardial infarction [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • Target vessel revascularization [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • Target lesion revascularization [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • Stent thrombosis [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • Major bleeding [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2017)
  • Acute gain [ Time Frame: procedure ]
    Change in the minimal lumen diameter from baseline to the final procedural angiogram. Acute angiographic parameter
  • Minimal lumen diameter [ Time Frame: procedure ]
    Acute angiographic parameter
  • Percent diameter stenosis [ Time Frame: procedure ]
    Acute angiographic parameter
  • Restenosis rate [ Time Frame: 6-9 months ]
    Late angiographic parameter
  • Percent diameter stenosis [ Time Frame: 6-9 months ]
    Late angiographic parameter
  • 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.
  • Net gain [ Time Frame: 6-9 months ]
    Is the difference between acute gain and late loss. Late angiographic parameter
  • Loss index [ Time Frame: 6-9 months ]
    Late angiographic parameter
  • 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.
  • Cardiac death [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • Total mortality [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • Myocardial infarction [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • Target vessel revascularization [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • Target lesion revascularization [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • Stent thrombosis [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • Major bleeding [ Time Frame: 1 year, 2 years, 3 years, 4 years, 5 years ]
    Individual clinical outcome
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon Pre-dilatation (RIBS VI Scoring)
Official Title  ICMJE Prospective Study of Bioresorbable Vascular Scaffold Treatment With Scoring Balloon Pre-dilatation in Patients With In-stent Restenosis
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary In-stent Restenosis
Intervention  ICMJE Device: Bioresorbable vascular scaffold. Absorb GT1 (Abbott)
Study Arms  ICMJE Experimental: BVS implantation in patients with ISR
BVS implantation in patients with ISR after scoring balloon pre-dilatation
Intervention: Device: Bioresorbable vascular scaffold. Absorb GT1 (Abbott)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03069066
Other Study ID Numbers  ICMJE RIBS VI scoring
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fernando Alfonso, Spanish Society of Cardiology
Study Sponsor  ICMJE Spanish Society of Cardiology
Collaborators  ICMJE
  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
  • Instituto de Investigación Sanitaria Hospital Universitario de la Princesa
  • Abbott Medical Devices
  • Terumo Medical Corporation
Investigators  ICMJE Not Provided
PRS Account Spanish Society of Cardiology
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP