Coronary Artery DiseasePhase 1/2NCT01701596
Safety and Efficacy of Rotational Atherectomy (RA) in Coronary Dissection
A Phase 1/2 study testing Immediate rotational atherectomy (RA) and Delayed rotational atherectomy (RA) in people with Coronary Artery Disease, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Immediate rotational atherectomy (RA) and Delayed rotational atherectomy (RA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- Aug 2004to Jun 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- acute myocardial infarction
- unprotected left main stenosis
- chronic total occlusion
- saphenous vein graft lesion
- cardiomyopathy
- severe valvular heart disease
Show all 9Show fewer
- NYHA functional class IV heart failure at baseline
- chronic renal failure on hemodialysis
- severe lung and liver disease or cancer
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Lesion Complicated by Coronary Dissection (RAISE)
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Immediate rotational atherectomy (RA), Delayed rotational atherectomy (RA)
- Keywords
- Rotational atherectomy, Coronary dissection, Percutaneous coronary intervention, Calcification
- Medical subject headings
- Coronary Artery Disease, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate rotational atherectomy (RA)Procedure or surgery
Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.
Delayed rotational atherectomy (RA)Procedure or surgery
Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection
| Study group | Role | What they receive |
|---|---|---|
| Rotational atherectomy (RA) | Experimental | Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection Receives: Procedure: Immediate rotational atherectomy (RA) |
| Delayed rotational atherectomy (RA) | Active comparator | Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection Receives: Procedure: Delayed rotational atherectomy (RA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause death
cardiac death and non-cardiac death
Measured: 4 years
Secondary outcomes (9)
Left ventricular ejection fraction (LVEF)
Measured: 4 years
6-min walk distance (6MWD)
Measured: 4 years
angina class
angina class according to the Canadian Cardiovascular Society (CCS) classification and Seattle Angina Questionnaire
Measured: 4 years
Non-fatal myocardial infarction
Measured: 4 years
Stent thrombosis
Measured: 4 years
Cardiac tamponade
Measured: 4 years
Stroke
Measured: 4 years
Target lesion revascularization
Measured: 4 years
New York Heart Association (NYHA) class IV heart failure
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2012 (estimated)
- Study startAug 2004
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chengxiang Li, M.D., Ph.D., Principal investigator, Department of Cardiolody, Xijing Hospital, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01701596
- Sponsor's protocol ID
- RAISE
- Status last verified
- Aug 2014
- First submitted
- 28 Sep 2012
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Lesion Complicated by Coronary Dissection (RAISE)
- ClinicalTrials.gov ID
- NCT01701596
- Acronym / sponsor ID
- RAISE
- Conditions
- Coronary Artery Disease
- Keywords
- Rotational atherectomy, Coronary dissection, Percutaneous coronary intervention, Calcification
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 5 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotational atherectomy (RA) | Experimental | Procedure: Immediate rotational atherectomy (RA)Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection |
| Delayed rotational atherectomy (RA) | Active comparator | Procedure: Delayed rotational atherectomy (RA)Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- acute myocardial infarction
- unprotected left main stenosis
- chronic total occlusion
- saphenous vein graft lesion
- cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate rotational atherectomy (RA)Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection. | Procedure or surgery | Rotational atherectomy (RA) |
| Delayed rotational atherectomy (RA)Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection | Procedure or surgery | Delayed rotational atherectomy (RA) |
Primary outcome
All cause death
Time frame: 4 years
cardiac death and non-cardiac death
9 secondary outcomes
Left ventricular ejection fraction (LVEF)
Time frame: 4 years
6-min walk distance (6MWD)
Time frame: 4 years
angina class
Time frame: 4 years
Non-fatal myocardial infarction
Time frame: 4 years
Stent thrombosis
Time frame: 4 years
Cardiac tamponade
Time frame: 4 years
Stroke
Time frame: 4 years
Target lesion revascularization
Time frame: 4 years
New York Heart Association (NYHA) class IV heart failure
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chengxiang Li, M.D., Ph.D. principal investigator
Department of Cardiolody, Xijing Hospital, Fourth Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Immediate rotational atherectomy (RA) and Delayed rotational atherectomy (RA) in people with Coronary Artery Disease, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause death (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2014.