Evidence map›Paper›PMID 35953406›Full record

ArticleCardiovascular revascularization medicine : including molecular interventions2022

One-Year Follow-Up of Vascular Intervention Trials Disrupted by the COVID-19 Pandemic: A Use-Case landscape.

Jennifer A Rymer, Ajay J Kirtane, Andrew Farb, Misti Malone, Michael R Jaff, Kirk Seward, Dan Stephens, Mark K Barakat, Mitchell W Krucoff

Open access · greenAbstract read
In one paragraph

Article in Cardiovascular revascularization medicine : including molecular interventions, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 1 country.

Jennifer A RymerDuke University School of Medicine, Durham, NC, United States of America; Duke Clinical Research Institute, Durham, NC, United States of America. Electronic address: jennifer.rymer@duke.edu.
Ajay J KirtaneColumbia University Irving Medical Center, New York, United States of America.
Andrew FarbUS Food and Drug Administration, Silver Spring, MD, United States of America.
Misti MaloneUS Food and Drug Administration, Silver Spring, MD, United States of America.
Michael R JaffBoston Scientific Corporation, Marlborough, MA, United States of America.
Kirk SewardMercator MedSystems, Inc., Emeryvlle, CA, United States of America.
Dan StephensBoston Scientific Corporation, Marlborough, MA, United States of America.
Mark K BarakatCeloNova BioSciences, San Antonio, TX, United States of America.
Mitchell W KrucoffDuke University School of Medicine, Durham, NC, United States of America; Duke Clinical Research Institute, Durham, NC, United States of America.
Boston Scientific (United States) · USUnited States Food and Drug Administration · USCelavie Biosciences (United States) · USClinical Research Institute · USColumbia University Irving Medical Center · USDuke University · USMercator MedSystems (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe COVID-19 pandemic had an unprecedented impact on cardiovascular clinical research. The decision-making and state of study operations in cardiovascular trials 1-year after interruption has not been previously described.

methodsIn the spring of 2020, we created a pandemic impact task force to develop a landscape of use case scenarios from 17 device trials of peripheral artery disease (PAD) and coronary artery disease (CAD) interventions. In conjunction with publicly available (clinictrials.gov) study inclusion criteria, primary endpoints and study design, information was shared for this use-case landscape by trial leadership and data owners.

resultsA total of 17 actively enrolling trials (9 CAD and 8 PAD) volunteered to populate the use case landscape. All 17 were multicenter studies (12 in North America and 5 international). Fifteen studies were industry-sponsored, of which 13 were FDA approved IDEs, one was PCORI-sponsored and two were sponsored by the NIH. Enrollment targets ranged from 150 to 9000 pts. At the time of interruption, 5 trials were <20 % enrolled, 9 trials were 50-80 % enrolled and 3 trials were >80 % enrolled. At 1 year, the majority of studies were continuing to enroll in the context of more sporadic but ongoing pandemic activity.

conclusionsAt 1 year from the first surge interruptions, most trials had resumed enrollment. Trials most heavily interrupted were trials early in enrollment and those trials not able to pivot to virtual patient and site visits. Further work is needed to determine the overall impact on vascular intervention trials disrupted during the COVID-19 pandemic.

Indexed as

COVID-19HumansPandemicsResearch DesignClinical trialsCOVID-19RemoteVascular

Identifiers

PMID35953406
PMCPMC9323208
OpenAlexW4288046020

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.