Trial · NCT03557385
Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
NCT03557385, Phase 4, Completed, Duke University; results first posted 2024-04-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adenosine Contrast CorrELations in Evaluating RevAscularizaTION. Trials, record NCT03557385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03557385
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
- NCT number
- NCT03557385
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 201 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Percutaneous Coronary Intervention
- Interventions
- Iopamidol, adenosine, Navvus® Catheter, CVi® Contrast Delivery System
- First posted
- 2018-06-15
- Last updated
- 2024-07-05
- Results first posted
- 2024-04-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) | Baseline | FFR is the ratio between the maximal myocardial flow measured in a diseased coronary artery and the theoretical maximal blood flow in the same territory in the absence of the stenosis, measured using adenosine induced hyperemia (aFFR) or contrast induced hyperemia (cFFR). Contrast FFR is being compared to the gold-standard adenosine FFR. An aFFR equal or less than 0.80 is the gold-standard cut-off to benefit from intervention. Reported as the percentage of agreement between aFFR and cFFR. |
| Primary | Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves | Baseline | The qualitative method comparison assesses the agreement as to which lesion is flow limiting. The contrast FFR measurement that corresponds to adenosine FFR measurement value of 0.8 will be used as the cutoff value for determining whether a lesion is flow limiting for contrast FFR. Reported as the percentage of agreement between aFFR and cFFR. |
| Secondary | Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | 30 days post procedure | (MACE: death, MI, and TVR) TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. An MI is caused by decreased or complete cessation of blood flow to a portion of the myocardium. |
| Secondary | Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | 1 year post procedure | (MACE: death, MI, and TVR) TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. An MI is caused by decreased or complete cessation of blood flow to a portion of the myocardium. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) | Baseline | All subjects received Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System. The FFR tracings of 217 lesions from 201 participants were assessed for quality and validity by the Fractional Flow Reserve Core Lab. After qualitative review, 192 FFR pairs were included in the analysis. | proportion of lesions with agreement | NUMBER |
| PRIMARY | Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves | Baseline | All subjects received Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System. The FFR tracings of 217 lesions from 201 participants were assessed for quality and validity by the Fractional Flow Reserve Core Lab. After qualitative review, 192 FFR pairs were included in the analysis. | proportion of lesions with agreement | NUMBER |
| SECONDARY | Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | 30 days post procedure | After quality assessment, 178 patients were included in the analysis | Events (composite of death, MI, or TVR) | NUMBER |
| SECONDARY | Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | 1 year post procedure | After quality assessment, 178 patients were included in the analysis | Events (composite of death, MI, or TVR) | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) | aFFR vs cFFR | 0.8922 | 95% Confidence Interval 0.8403 to 0.9441 | proportion of lesions with agreement | |
| Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves | aFFR vs cFFR | 0.8912 | 95% Confidence Interval 0.8445 to 0.9379 | proportion of lesions with agreement | |
| Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | Per Protocol Study Population | 3 | Events (composite of death, MI, or TVR) | ||
| Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | Per Protocol Study Population | 13 | Events (composite of death, MI, or TVR) |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| aFFR | STARTED | aFFR and cFFR | 201 | |
| aFFR | COMPLETED | aFFR and cFFR | 201 | |
| aFFR | NOT COMPLETED | aFFR and cFFR | 0 | |
| cFFR | STARTED | aFFR and cFFR | 201 | |
| cFFR | COMPLETED | aFFR and cFFR | 201 | |
| cFFR | NOT COMPLETED | aFFR and cFFR | 0 |
Source ClinicalTrials.gov
Adverse events1
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Myocardial infarction | Cardiac disorders | aFFR vs cFFR | 6 | 201 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | aFFR vs cFFR | 7 | 201 |
| Total, other adverse events | aFFR vs cFFR | 0 | 201 |
| Total, serious adverse events | aFFR vs cFFR | 6 | 201 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40270240 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03557385
GET https://conductscience.org/api/trials/v1/NCT03557385/registered