Clincosm LogoSign in Get a demo

CHANCE: Outcome of CHAllenging lesioNs and Patients Treated With Polymer Free Drug-CoatEd Stent

Sponsor
Azienda Ospedaliera Città della Salute e della Scienza di Torino (Other)
Overall Status
Completed
CT.gov ID
NCT03622203
Collaborator
(none)
1,000
Enrollment
28
Actual Duration (Months)

Study Details

Study Description

Brief Summary

Length of DAT (Dual Antiplatelet therapy) represents one of the most challenging choices for interventional cardiologist.

Prolonged DAT reduces risk of subsequent MI (Myocardial Infarction) with an increase in major bleedings, consequently with a neutral effect on survival [1].

Recently a Polymer-free Drug-Coated coronary stent has been tested in a randomized controlled trial with only one month of DAT due to its peculiar features, with an increased efficacy compared to BMS (Bare Metal Stent) and with a not negligible risk of ST at one year (about 2%)[2,3].

The RCT despite its promising design (inclusion of high risk patients like those with previous bleeding or with severe renal disease) showed a major limitation, that is:

  1. patients who are often offered a Biofreedom in real life, that is those with active cancer or needing major surgery or on OAT (Oral Anticoagulation)

  2. and patients with bifurcation and multivessel disease, that is those with an increased risk of ST [4]

  3. STEMI patients [5] were underrepresented (less than 30%). Consequently we performed this multicenter study to evaluate safety and efficacy of Biofreedom in real life patients.

POCE (a composite end point of death, myocardial infarction, target lesion revascularization) and DOCE (cardiac death, MI-TLR and TLR) will be the primary end points, while its single components will be the secondary ones along stent thrombosis and with bleedings (Barc classification).

At least 12 months The Leaders FREE (2) reported an incidence of MACE of 9.4% at one year in overall patients. If there is a true difference in favour of the experimental treatment of 1.2%, then 870 patients are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference when compared to non selected patients of more than 2% [5]

All patients implanting Biofreedom with these prespecified analysis:
  1. Clinical

  • Diabetic patients (both insulin and not insulin depenent)

  • Requiring oral anticoagulation

  • On active cancer (that is requiring chemio or radio-therapy and or surgery)

  • Requiring surgery

  • STEMI

  1. Interventional

  • Bifurcation (both provisional both 2 stents)

  • Multivessel

  • Ostial

Condition or Disease Intervention/Treatment Phase
  • Device: Biofreedom

Detailed Description

Our interest is to test the performance of these stents in real life patients

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Outcome of CHAllenging lesioNs and Patients Treated With Polymer Free Drug-CoatEd Stent ("Biofreedom"): the CHANCE a Multicenter Study
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Jan 31, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Real life patients

Patients who are often offered a Biofreedom in real life, that is those with active cancer or needing major surgery or on OAT (Oral Anticoagulation)

Device: Biofreedom
Use of Biofreedom in real life patients
Difficult coronary lesions

Patients with bifurcation and multivessel disease, that is those with an increased risk of ST

Device: Biofreedom
Use of Biofreedom in real life patients
STEMI

Patients with STEMI

Device: Biofreedom
Use of Biofreedom in real life patients

Outcome Measures

Primary Outcome Measures

  1. Incidence of POCE (primary patient-oriented endpoint) [At least 6 months]

    Incidence of POCE (a composite and mutual exclusive end point of death, myocardial infarction, target lesion revascularization)

Secondary Outcome Measures

  1. Incidence of Death [At least 6 months]

    Incidence of Death

  2. Incidence of Myocardial Infarction [At least 6 months]

    Incidence of Myocardial Infarction

  3. Incidence of TLR [At least 6 months]

    Incidence of target lesion revascularization

  4. Incidence of Cardiac Death [At least 6 months]

    Incidence of Cardiac Death

  5. Incidence of MI-TLR [At least 6 months]

    Incidence of Myocardia Infarction TLR

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Clinical

  • Diabetic patients (both insulin and not insulin depenent)

  • Requiring oral anticoagulation

  • On active cancer (that is requiring chemio or radio-therapy and or surgery)

  • Requiring surgery

  • STEMI

  1. Interventional

  • Bifurcation (both provisional both 2 stents)

  • Multivessel

  • Ostial

Exclusion

  1. clinical less than 18 years old or more than 80

  2. interventional last remaing vessel

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

Investigators

  • Principal Investigator: Fabrizio D'Ascenzo, Città della Salute e Della Scienza di Torino

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fabrizio D'Ascenzo, Principal Investigator, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier:
NCT03622203
Other Study ID Numbers:
  • CHANCE
First Posted:
Aug 9, 2018
Last Update Posted:
Aug 9, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Coronary Disease

Study Results

No Results Posted as of Aug 9, 2018