Terumo’s Cross-Seal Suture-Mediated Vascular Closure Device System Studied in IDE Trial

November 4, 2022—The objective of the prospective, multicenter, single-arm Cross-Seal investigational device exemption (IDE) trial was to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device (Terumo Interventional Systems) in obtaining hemostasis at the target limb access site after interventional procedures using 8- to 18-F procedural sheaths.

Prakash Krishnan, MD, presented the findings in the second of three Late-Breaking Clinical Trials sessions at the VIVA22 conference held by the VIVA Foundation on October 31 to November 3 in Las Vegas, Nevada.

As summarized in the VIVA Foundation press release, the trial included patients undergoing transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty, or endovascular thoracic or infrarenal aortic aneurysm repair (TEVAR/EVAR) using 8- to 18-F sheath sizes.

The study’s primary efficacy endpoint was time to hemostasis (TTH) at the target limb access site, and the primary safety endpoint was freedom from major complications of the target limb access site within 30 days.

A total of 147 patients were enrolled in the study between August 9, 2019, and March 12, 2020. TAVR was performed in 53.7% (79/147) of patients. Percutaneous TEVAR/EVAR was performed in 46.3% (68/147). The mean sheath inner diameter was 15.5 ± 1.8 mm.

Dr. Krishnan reported that the primary effectiveness endpoint of TTH was 0.4 ± 1.4 minutes; the median time was 0.05 minutes (IQR, 0.017-0.15 minutes).

Adjunctive intervention was required in 9.2% (13/142) of patients, of which 2.1 (3/142) were surgical and 5.6% (8/142) were endovascular. Technical success was achieved in 92.3% (131/142) of patients.

Freedom from major complications of the target limb access site was 94.3% (83/88), noted the VIVA Foundation press release.