NCT01701596

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for phase_1 coronary-artery-disease

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_1 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

8.8 years

First QC Date

September 28, 2012

Last Update Submit

August 18, 2014

Conditions

Coronary Artery Disease

Keywords

Rotational atherectomyCoronary dissectionPercutaneous coronary interventionCalcification

Outcome Measures

Primary Outcomes (1)

  • All cause death

    cardiac death and non-cardiac death

    4 years

Secondary Outcomes (9)

  • Left ventricular ejection fraction (LVEF)

    4 years

  • 6-min walk distance (6MWD)

    4 years

  • angina class

    4 years

  • Non-fatal myocardial infarction

    4 years

  • Stent thrombosis

    4 years

  • +4 more secondary outcomes

Study Arms (2)

Rotational atherectomy (RA)

EXPERIMENTAL

Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection

Procedure: Immediate rotational atherectomy (RA)

Delayed rotational atherectomy (RA)

ACTIVE COMPARATOR

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

Procedure: Delayed rotational atherectomy (RA)

Interventions

Immediate rotational atherectomy (RA)PROCEDURE

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

Rotational atherectomy (RA)
Delayed rotational atherectomy (RA)PROCEDURE

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

Delayed rotational atherectomy (RA)

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCalcinosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Chengxiang Li, M.D., Ph.D.

    Department of Cardiolody, Xijing Hospital, Fourth Military Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2012

First Posted

October 5, 2012

Study Start

August 1, 2004

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

CN(1)