RISCC Goal

Collecting and reporting high quality & credibility data on CTO patients and procedures in Israel.

RISCC Definitions and Main Protocol Components

  • A prospective registry that aims to report the results of CTO PCI’s performed by a dedicated CTO operator, according to CTO hybrid approach, clinical follow up and patients’ outcome.
  • The Registry will include all consecutive CTO attempts and all patients that will be evaluated in CTO Clinic under institutional CTO program.
  • Baseline angiography, echocardiography and ischemia assessment is mandatory for patients’ enrollment into CTO program.
  • Dual injection, and hybrid algorithm utilization is mandatory.
  • All patients will be followed for 12 months to assess the efficacy outcome in terms of procedure success, mortality, subsequent morbidity and ischemia relief and also the safety outcome in terms of rate of complications.
  • Follow up visit will be scheduled at ~1 month to assess acute clinical outcome and adverse events (kidney and skin condition).
  • At ~12 months the follow up telephone call or visit will be held to assess clinical status.
  • Echocardiography and/or ischemia assessment (SPECT or Stress ECG/Stress Echo) will be performed at ~12 month.
  • Repeated angiography will be performed on operators’ discretion according to clinical considerations.

Patients’ enrollment

Inclusion criteria

  • Age 18 - 99 years.
  • Presence of CTO.
  • Patients eligible for CTO PCI according to current standards of care.
  • Rest echocardiography.
  • Ischemia evaluation.
  • At least 1 week after another non-CTO lesion had been treated.
  • Patient and center ability for long term (at least 1 year) follow-up as a part of a dedicated institutional CTO program.
  • Informed consent.

Exclusion criteria

  • Revascularization in the setting of acute coronary syndrome.
  • Revascularization strategy other than CTO hybrid algorithm.
  • Exclusion criteria for implantation of a drug-eluting stent.
  • Inability to complete follow up (significant co-morbidity or functional impairment, short life expectancy).
  • Inability to give consent (custody).

RISCC Participant’s Obligations

Convention

Participant undertakes to comply with transparency and accuracy of the reported cases (incl. number, classification, complications, failures and deferred cases).

Commitment

Allowed to participate only dedicated CTO operators, conducting a specialized CTO clinic for patients’ evaluation and follow up and performing at least 12 CTO PCI attempts per year.

Compliance

Prerequisites for participation are: protocol approval by local ethic board (Helsinki), acceptance and adherence to the protocol, utilization of hybrid approach with dual injections, transparency, readiness to disclose any of the reported cases, maximal data upload to CRF.

RISCC Participant’s Commitment Statement

I agree to comply with the above obligations of the Registry Participant and I promise to act in good faith and in full accordance to them. I agree and undertake to comply with the above protocol and patient enrollment criteria.
Disagree
I Agree