Weekly vascular bulletin — October 5, 2026

Period covered: September 28 to October 5, 2026. A week dominated by venous disease: The VEINS 2026 (Las Vegas, October 3-4) presented eight late-breaking studies, including the 24-month follow-up of the randomized C-TRACT trial. There were no new peripheral arterial data, only announcements: the VIVA 2026 late-breaking trials (sirolimus-coated balloons, below-the-knee lithotripsy, PESTO-CFA, PROMISE III) are being presented this week and will appear in the next issue. Eleven verified items; the venous section therefore comes first.

Venous disease

1. C-TRACT at 24 months: iliac vein stenting improves quality of life in post-thrombotic syndrome

[Clinical trial] [Meeting] [USA]

NIH-funded randomized trial at 29 US centers in 225 patients with post-thrombotic syndrome and iliac vein obstruction: endovascular therapy with iliac vein stenting plus standard care versus standard care alone. At 24 months (197 with quality-of-life assessments), VEINES-QOL was 63.5 vs 53.0 (difference 10.5; p<0.001) and SF-36 physical component 56.3 vs 51.2 (p=0.006). Symptomatic recurrent VTE 2.1% vs 7.1%; major bleeding 4.1% vs 2.0%. Presented by Suresh Vedantham at The VEINS 2026.

Why it matters: This is the best randomized evidence available for stenting in post-thrombotic syndrome, and it is independent of industry; however, the trial was open label, the outcome is subjective, 12% of assessments are missing and major bleeding doubled. Meeting data, with no peer-reviewed publication of this analysis yet.

https://viva-foundation.org/news-article?id=220762

2. BOLT: aspiration thrombectomy for acute iliofemoral DVT, primary results of the IDE study

[Clinical trial] [Meeting] [USA]

Prospective, multicenter, single-arm IDE study: 229 patients at 39 US sites (mean age 58.1 years; 62% women) with acute iliofemoral DVT treated with computer-assisted vacuum thrombectomy (CAVT). Thrombus reduction ≥75% in 98.0% (198/202); 48-hour major adverse events 3.1% (7/229); device time 18 minutes; 99.1% single-session. At 30 days: major adverse events 7.6% and re-thrombosis 3.9%; Villalta score from 11.0 to 1.0. Presented by Patrick Muck.

Why it matters: Single-arm, manufacturer-sponsored and measured against performance goals: it shows the device removes thrombus with acceptable safety, not that it reduces post-thrombotic syndrome compared with anticoagulation alone. A 30-day Villalta score is too early to support conclusions.

https://viva-foundation.org/news-article?id=220762

3. Spectrum in C6 disease: cyanoacrylate closure for active venous ulcers, 24 months

[Clinical trial] [Meeting] [USA and Europe]

Prospective single-arm study of VenaSeal (Medtronic) in 125 patients with C6 disease at 17 sites in the USA and Europe. Through 24 months: ulcer healing 88.1%, median time to healing 92 days (95% CI 74-137), recurrence 22.9%, probability of anatomic vein closure 78.0%. Sub-ulcer sclerotherapy was used in 21.6% (27/125). No device-related events after 6 months. Presented by Manj Gohel.

Why it matters: Healing figures are comparable to those of early thermal ablation, but there is no comparator and the study belongs to the manufacturer; anatomic closure of 78% at two years deserves scrutiny. Not practice-changing: it confirms cyanoacrylate as a reasonable option in C6.

https://viva-foundation.org/news-article?id=220756

4. VEnice: FDA clears a percutaneous clip for ligation of superficial and perforator veins

[Regulatory FDA] [Meeting] [Italy]

VCD Medical (Brescia) announced on September 29 the 510(k) clearance of VEnice: an implantable clip pre-loaded in a 17-gauge needle applicator with an integrated suture cutter, deployed under ultrasound to compress and occlude the vein, percutaneously or surgically. The interim analysis of BERG02 was presented at The VEINS (single-center, nonrandomized, 22 patients, clip combined with sclerotherapy): 22 great saphenous veins, 3 anterior saphenous veins and 11 perforators treated, mean proximal GSV diameter 8.44 mm, technical success 100%, 1 to 2 minutes per clip, no device-related serious adverse events at 30 days. At one month 22/22 GSVs and 10/11 perforators remained closed; 6-month data exist for only 8 GSVs and 3 perforators, all closed.

Why it matters: This is mechanical ligation with no heat, no tumescence and no adhesive, a concept of direct interest to anyone developing saphenous occlusion; but the evidence is 22 patients from one center, with adjunctive sclerotherapy confounding the effect of the clip, and the primary endpoint (core-lab closure at 12 months) is not yet available. A 510(k) clearance does not require comparative clinical efficacy.

https://www.dicardiology.com/content/vein-closure-device-receives-fda-clearance
https://viva-foundation.org/news-article?id=220756

5. Abre venous stent: real-world registry, first 30 days

[Meeting] [Industry] [USA and Europe]

Medtronic prospective post-market registry (NCT01524276): 151 patients at 15 sites enrolled from June 2024 to September 2025; 72.8% women, mean age 50.6 years. Indications: nonthrombotic iliac vein lesion 74.3%, post-thrombotic syndrome 21.1%, acute DVT 3.3%; pelvic venous disorder in 45.7%. Mean stented length 150.5 mm. At 30 days: no fractures and one target lesion revascularization (0.7%). Stents of 18 to 20 mm caused more immediate pain, resolved by day 30.

Why it matters: Thirty days say nothing about venous stent durability; what matters is the pattern of use: three of four implants were for nonthrombotic lesions, the indication with the weakest evidence. The efficacy endpoint is planned at 60 months.

https://viva-foundation.org/news-article?id=220756

6. Recana: mechanical thrombectomy for venous in-stent restenosis

[Meeting] [Industry] [Multicenter]

Prospective multicenter analysis of the Recana system for chronic in-stent restenosis and residual vein obstruction, presented by Stephen Black. Primary endpoint (effective diameter ≥50% by intravascular ultrasound at the end of the procedure): 96.2%. Mean lumen area increased from 12.5 to 92.7 mm². Mean procedure time 107 minutes, length of stay 1.4 days, general anesthesia in 100% of cases.

Why it matters: It addresses a real problem with no good solution, but the release does not report the number of patients, follow-up or late patency; the endpoint is purely intraprocedural and the procedure is long and performed under general anesthesia.

https://viva-foundation.org/news-article?id=220762

7. Catheter-based pulmonary embolism therapy: STRIKE-PE at one year and RAPID-PE interim analysis

[Clinical trial] [Meeting] [International / USA]

STRIKE-PE (prospective, international, single-arm, CAVT for intermediate- or high-risk PE): 1,000 patients treated, 522 with one-year follow-up analyzed. RV/LV ratio from 1.38 to 0.97 at 48 hours (27.2% reduction; p<0.001); 48-hour major adverse events 1.9%; 30-day mortality 1.7%; recurrent symptomatic PE 0.6%; dyspnea and quality of life improved by 90 days. RAPID-PE (prospective, multicenter, single-arm, mechanically channeled thrombolysis with the Thrombolex device, four 1-mg pulses of dilute r-tPA per lung): interim analysis of 150 patients with intermediate-risk PE (baseline RV/LV 1.40; bilateral in 93.3%). Death or hemodynamic decompensation at 7 days 0.7% (1/150); major bleeding at 72 hours 0.7%; no strokes; recurrent PE at 30 days 2.7%; only 10% required intensive care after treatment.

Why it matters: Two manufacturer-sponsored single-arm series with surrogate endpoints (RV/LV ratio), and nearly half of STRIKE-PE without analyzed one-year follow-up. They are consistent with the known safety profile, but the clinical question (catheter versus anticoagulation alone in intermediate risk) can only be answered by randomized trials.

https://viva-foundation.org/news-article?id=220762
https://viva-foundation.org/news-article?id=220756

Peripheral arterial disease and calcium

8. IN.PACT BTK: FDA Breakthrough Device designation for a below-the-knee paclitaxel-coated balloon

[Regulatory FDA] [Industry] [USA]

Medtronic announced Breakthrough Device designation for the IN.PACT BTK balloon (paclitaxel with FreePac coating), investigational for infrapopliteal lesions in chronic limb-threatening ischemia. It plans the global, randomized pivotal trial IN.PACT BTK DELTA, with about 400 patients; global principal investigator, Eric Secemsky. The announcement provides no new clinical results.

Why it matters: The designation speeds interaction with the FDA; it is not evidence of efficacy. The precedent is worth remembering: the same company's earlier infrapopliteal paclitaxel balloon showed no benefit in IN.PACT DEEP and was withdrawn from the market more than a decade ago. Until randomized data exist, nothing changes.

https://vascularnews.com/medtronic-receives-us-fda-breakthrough-device-designation-for-in-pact-btk-drug-coated-balloon/
https://evtoday.com/news/medtronics-inpact-btk-dcb-earns-FDA-breakthrough-device-designation

9. China: an absorbable covered peripheral stent enters the NMPA special review pathway

[Regulatory NMPA] [China]

The NMPA device evaluation center published on September 28 notice No. 16 of 2026, listing seven products admitted to the special review procedure for innovative devices. Among them is an absorbable, balloon-expandable, covered peripheral stent system (可吸收外周球扩覆膜支架系统) from Yuanxin Technology (元心科技, Shenzhen), a company devoted to biodegradable iron vascular scaffolds with product lines for coronary disease, pediatric pulmonary vascular stenosis and below-the-knee arteries. (source in Chinese)

Why it matters: Entering the priority pathway is not an approval, and no clinical data on the device have been published; the source is a trade press report on the official notice, not the dossier. It matters as a signal that absorbable iron scaffolds are moving into the peripheral territory.

https://m.163.com/dy/article/L7U71JO305340BZM.html

Carotid and aortic disease

10. CREST-2: revascularization of asymptomatic carotid stenosis does not improve cognition

[Publication] [Clinical trial] [USA / international]

JAMA published the cognitive results of the two parallel CREST-2 randomized trials (Lazar et al.): in severe asymptomatic carotid stenosis there were no significant differences in learning, attention, memory or executive function between revascularization plus medical therapy and medical therapy alone, with results consistent across age, sex and stenosis severity and maintained at 4 years. In the hemodynamic substudy CREST-H (291 patients, mean age 70 years, 17.5% with baseline cognitive impairment), perfusion changes at one year were not associated with cognitive improvement.

Why it matters: It removes a common argument for intervening in asymptomatic patients: the indication should be discussed only in terms of stroke prevention. Limitation of this summary: it is based on TCTMD coverage, which does not reproduce the effect sizes of the original article.

https://www.tctmd.com/news/more-data-affirm-no-cognitive-benefits-carotid-revascularization-crest-2

11. Gore Excluder IBE Plus: first patients in the pivotal study

[Industry] [USA]

Gore started the pivotal study of the Excluder IBE Plus iliac branch endoprosthesis, an investigational device for aortoiliac and common iliac artery aneurysms. Prospective, multicenter, nonrandomized design with two arms at about 30 US sites and five-year follow-up. First implants at the University of Maryland (Shahab Toursavadkohi, national principal investigator) and Orlando (Aleem Mirza).

Why it matters: This is the start of enrollment, with no clinical data; it does not change practice. Worth following for internal iliac preservation in anatomies currently outside the indication.

https://vascularnews.com/first-patient-enrolled-in-gore-excluder-ibe-plus-stent-graft-pivotal-study/

Regional coverage: searches were run in Japanese, Chinese, Korean, Russian, Portuguese, Arabic, Turkish and German. Apart from the NMPA notice, nothing verifiable and dated within the last 7 days was found this week from Japan, Korea, India, Russia, the Middle East, Turkey, Brazil or the rest of Latin America; no filler was added. The JVS, JVS-Venous and Lancet landing pages could not be opened (access blocked), so this week no items come directly from those journals.

Upcoming meetings and dates

• VIVA 2026, Las Vegas: under way this week. Late-breaking trials pending: SELUTION4SFA at 12 months, SirPAD femoropopliteal subgroup, SUCCESS PTA at 24 months, DISRUPT PAD BTK II, POWER PAD II, PESTO-CFA (percutaneous versus surgery for the common femoral artery), PROMISE III at one year, real-world Esprit BTK.
• ESVS Annual Meeting: October 6-9, Belgrade.
• EVTM Symposium: October 8-10, Chiba, Japan.
• SITE 2026: October 14-16, Santiago de Compostela.
• DFCon (diabetic foot): October 22-24, Anaheim.
• AMP Europe: October 26-28, Amsterdam.
• TCT 2026: October 31 to November 3, San Diego.
• Further ahead: SILAN, November 4-7, Guadalajara; Venous Symposium Europe, November 12-14, Athens; VEITHsymposium, November 17-21, New York.

https://evtoday.com/calendar/2026
https://viva-foundation.org/news-article?id=220426

Weekly vascular bulletin — October 5, 2026

11 verified items from The VEINS 2026, JAMA, the FDA and China's NMPA. A venous week.

Three worth your time:
• C-TRACT at 24 months (NIH, 225 randomized patients): iliac vein stenting in post-thrombotic syndrome improved VEINES-QOL (63.5 vs 53.0). Open label, subjective outcome, and major bleeding 4.1% vs 2.0%.
• BOLT (229 patients, acute iliofemoral DVT): ≥75% thrombus reduction in 98% with aspiration thrombectomy. Single-arm, manufacturer-sponsored; it does not show less post-thrombotic syndrome.
• VEnice: FDA clears a percutaneous clip for saphenous and perforator ligation. BERG02: 22 patients, 22/22 GSVs closed at one month; only 8 have 6-month data.

Full bulletin, with a critical reading of each study and links to primary sources:
https://boletinesmedicos.com/en/vascular/2026-10-05.html

#VascularSurgery #Endovascular #VenousDisease #DVT #Phlebology

C-TRACT at 24 months: iliac vein stenting in post-thrombotic syndrome, VEINES-QOL 63.5 vs 53.0 (major bleeding 4.1% vs 2.0%). BOLT: thrombectomy for iliofemoral DVT, ≥75% clot removal in 98%, single arm.
https://boletinesmedicos.com/en/vascular/2026-10-05.html