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Completed

NCT Number: NCT01701596

Safety and Efficacy of Rotational Atherectomy (RA) in Coronary Dissection

This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure.

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Key information

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

About this study

Coronary artery dissection is a contraindication for the use of rotational atherectomy, since rotational atherectomy may propagate coronary dissection. In the presence of coronary dissection, conservative management is suggested for approximately 4 weeks to permit the dissection to heal prior to treatment with rotational atherectomy. However, a lot of patients have frequent angina attacks and some patients develop serious complications including abrupt vessel closure during this period. Thus, immediate strategies cope with coronary dissection induced by balloon dilation is needed for the early recovery of those patients. The present study was performed to compare the safety and efficacy of immediate RA and delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 30 and 85 years old
  • nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure
  • Coronary artery dissection type A, B and type C according to the National Heart, Lung and Blood Institute (NHLBI) coronary dissection criteria

Exclusion criteria

  • acute myocardial infarction
  • unprotected left main stenosis
  • chronic total occlusion
  • saphenous vein graft lesion
  • cardiomyopathy
  • severe valvular heart disease
  • NYHA functional class IV heart failure at baseline
  • chronic renal failure on hemodialysis
  • severe lung and liver disease or cancer

Treatment and study plan

Immediate rotational atherectomy (RA)

Procedure

Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.

Delayed rotational atherectomy (RA)

Procedure

Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection

Primary outcomes

  1. All cause death

    Time frame: 4 years

    cardiac death and non-cardiac death

Secondary outcomes

  1. Left ventricular ejection fraction (LVEF)

    Time frame: 4 years

  2. 6-min walk distance (6MWD)

    Time frame: 4 years

  3. angina class

    Time frame: 4 years

    angina class according to the Canadian Cardiovascular Society (CCS) classification and Seattle Angina Questionnaire

  4. Non-fatal myocardial infarction

    Time frame: 4 years

  5. Stent thrombosis

    Time frame: 4 years

  6. Cardiac tamponade

    Time frame: 4 years

  7. Stroke

    Time frame: 4 years

  8. Target lesion revascularization

    Time frame: 4 years

  9. New York Heart Association (NYHA) class IV heart failure

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Lesion Complicated by Coronary Dissection (RAISE)

Important dates

Study start
2004
Primary completion
2013
Study completion
2013
First posted
Oct 5, 2012
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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